Relevant bibliographies by topics / Rules of medical device

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers
  6. Reports

Academic literature on the topic 'Rules of medical device'

Author: Grafiati
Published: 4 June 2021
Last updated: 3 February 2022

Create a spot-on reference in APA, MLA, Chicago, Harvard, and other styles

Select a source type:

Consult the lists of relevant articles, books, theses, conference reports, and other scholarly sources on the topic 'Rules of medical device.'

Next to every source in the list of references, there is an 'Add to bibliography' button. Press on it, and we will generate automatically the bibliographic reference to the chosen work in the citation style you need: APA, MLA, Harvard, Chicago, Vancouver, etc.

You can also download the full text of the academic publication as pdf and read online its abstract whenever available in the metadata.

Journal articles on the topic "Rules of medical device"

1

Sharma, Damini, and Amrish Chandra. "Medical Device Rules - 2017, India: An Insight." Applied Clinical Research, Clinical Trials and Regulatory Affairs 7, no. 2 (July 14, 2020): 126–34. http://dx.doi.org/10.2174/2666255813666190912114043.

Full text
Abstract:
According to “Medical Device Rules-2017” (MDR-2017), “Medical Devices (MDs) are the substances which are used for in-vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood, and blood component collection bag with or without anticoagulant and substances including mechanical contraceptives, disinfectants and insecticides and devices notified from time to time under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940”. According to this definition, MDs are classified into four classes: - class A, class B, class C and class D. The purpose of this review article is to present an overview of the regulatory registration requirement of MD in India according to the new MDR-2017.
APA, Harvard, Vancouver, ISO, and other styles
2

Owens, Brian. "Stronger rules needed for medical device cybersecurity." Lancet 387, no. 10026 (April 2016): 1364. http://dx.doi.org/10.1016/s0140-6736(16)30120-9.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Миронова, Анфиса, and Anfisa Mironova. "Developments in Rules of state registration of medical devices." Vestnik Roszdravnadzora 2019, no. 3 (June 26, 2019): 24–27. http://dx.doi.org/10.35576/article_5d135f4a159e30.48455158.

Full text
Abstract:
This article dedicated to analysis of the key developments in the legal and regulatory environment in a circulation of medical devices in the Russian Federation in regard to procedure of state registration of medical devices, as well as amending documents of the registration dossiers of the medical device, which have to be taken into account by the applicant in the process of submission of documents to Roszdravnadzor.
APA, Harvard, Vancouver, ISO, and other styles
4

Targhotra, Monika, Geeta Aggarwal, Harvinder Popli, and Madhu Gupta. "Regulatory aspects of medical devices in India." International Journal of Drug Delivery 9, no. 2 (October 6, 2017): 18. http://dx.doi.org/10.5138/09750215.2147.

Full text
Abstract:
<p>Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines. Medical device manufacturing in India should be taken seriously due to large population and the potential severity of the consequences of introducing inferior and unsafe products to the market-place. Therefore a law containing adequate guidelines of rules and regulations are required for monitoring the entry of such devices into the use in public health. The regulations define requirements of medical device design, development and manufacture to ensure that products reaching market are safe and effective. Presently in India regulatory body CDSCO is governing regulation for regulation of devices which with time, amendment introducing in the law will provide safety assurance to public health. This review provides a study on different regulatory aspects of medical device implemented in India. The present review discuss about the classification of medical devices and regulations aspects in India.</p>
APA, Harvard, Vancouver, ISO, and other styles
5

Peter, Lukas, Ladislav Hajek, Petra Maresova, Martin Augustynek, and Marek Penhaker. "Medical Devices: Regulation, Risk Classification, and Open Innovation." Journal of Open Innovation: Technology, Market, and Complexity 6, no. 2 (June 10, 2020): 42. http://dx.doi.org/10.3390/joitmc6020042.

Full text
Abstract:
In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.
APA, Harvard, Vancouver, ISO, and other styles
6

Keutzer, Lina, and Ulrika SH Simonsson. "Medical Device Apps: An Introduction to Regulatory Affairs for Developers." JMIR mHealth and uHealth 8, no. 6 (June 26, 2020): e17567. http://dx.doi.org/10.2196/17567.

Full text
Abstract:
The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.
APA, Harvard, Vancouver, ISO, and other styles
7

Shaik, Ayesha bi, and G. Ramakrishna. "Registration Process of Medical Devices in CIS Countries." International Journal of Drug Regulatory Affairs 9, no. 2 (June 16, 2021): 35–42. http://dx.doi.org/10.22270/ijdra.v9i2.468.

Full text
Abstract:
The Commonwealth of Independent States (CIS) is a region with constant, and often quite radical, changes in medical device regulations. This article summarizes the most significant new regulations in the largest CIS countries in order to provide a clearer picture of the regulatory requirements for medical devices in the region. The article also examines the new registration procedure for medical devices placed on the common market within the Eurasian Economic Union (EAEU) in accordance with the International Treaty within the EAEU. This Treaty defines the common principles and rules of circulation of medicinal products and medical devices.
APA, Harvard, Vancouver, ISO, and other styles
8

Gomez, Ann Lydia, D. Nagasamy Venkatesh, and Niveditha Neelakandan. "A comparative study of medical device regulations in India: Before and after the implementation of medical device rules 2017." Research Journal of Pharmacy and Technology 13, no. 9 (2020): 4423. http://dx.doi.org/10.5958/0974-360x.2020.00782.9.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Mukhtar, Hamid, Saeed Rubaiee, Moez Krichen, and Roobaea Alroobaea. "An IoT Framework for Screening of COVID-19 Using Real-Time Data from Wearable Sensors." International Journal of Environmental Research and Public Health 18, no. 8 (April 12, 2021): 4022. http://dx.doi.org/10.3390/ijerph18084022.

Full text
Abstract:
Experts have predicted that COVID-19 may prevail for many months or even years before it can be completely eliminated. A major problem in its cure is its early screening and detection, which will decide on its treatment. Due to the fast contactless spreading of the virus, its screening is unusually difficult. Moreover, the results of COVID-19 tests may take up to 48 h. That is enough time for the virus to worsen the health of the affected person. The health community needs effective means for identification of the virus in the shortest possible time. In this study, we invent a medical device utilized consisting of composable sensors to monitor remotely and in real-time the health status of those who have symptoms of the coronavirus or those infected with it. The device comprises wearable medical sensors integrated using the Arduino hardware interfacing and a smartphone application. An IoT framework is deployed at the backend through which various devices can communicate in real-time. The medical device is applied to determine the patient’s critical status of the effects of the coronavirus or its symptoms using heartbeat, cough, temperature and Oxygen concentration (SpO2) that are evaluated using our custom algorithm. Until now, it has been found that many coronavirus patients remain asymptomatic, but in case of known symptoms, a person can be quickly identified with our device. It also allows doctors to examine their patients without the need for physical direct contact with them to reduce the possibility of infection. Our solution uses rule-based decision-making based on the physiological data of a person obtained through sensors. These rules allow to classify a person as healthy or having a possibility of infection by the coronavirus. The advantage of using rules for patient’s classification is that the rules can be updated as new findings emerge from time to time. In this article, we explain the details of the sensors, the smartphone application, and the associated IoT framework for real-time, remote screening of COVID-19.
APA, Harvard, Vancouver, ISO, and other styles
10

Chauhan, Pratibha, and Rahul Chauhan. "CONDUCIVE ENVIROMENT FOR FOSTERING INDIA SPECIFIC INNOVATION: NEW MEDICAL DEVICE RULES 2017." International Journal of Drug Regulatory Affairs 5, no. 3 (September 16, 2017): 20–26. http://dx.doi.org/10.22270/ijdra.v5i3.203.

Full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Dissertations / Theses on the topic "Rules of medical device"

1

Foe, Owono Guy. "Impact of EU Medical Device Directive on Medical Device Software." ScholarWorks, 2015. https://scholarworks.waldenu.edu/dissertations/353.

Full text
Abstract:
Directive 2007/47/EC of the European Parliament amending Medical Device Directive (MDD) provides medical device manufacturers with a compliance framework. However, the effects of the amendments to the MDD on competition in the U.S. medical device software industry are unknown. This study examined the impact of this directive on the competitiveness of U.S. medical device software companies, the safety and efficacy of medical device software, employee training, and recruitment. The conceptual framework for this study included 3 dimensions of medical device regulations: safety, performance, and reliability. The overall research design was a concurrent mixed method study using both quantitative and qualitative techniques. The qualitative techniques involved case studies of 5 purposively selected companies. Data collection involved both surveys and interviews. The sample consisted of 56 employees within medical device firms with markets around the European regions. Qualitative data analysis consisted of descriptive thematic analysis along the study questions and hypotheses and summative evaluation. Quantitative data analysis included descriptive statistics and correlation to test the 4 hypotheses. The results suggested that the MDD has realigned medical device software manufacturing practices, and US medical device companies have gained global competitiveness in improving product safety and increasing sales revenue. Key recommendations to medical device manufacturers include adopting MDD 93/42/EEC, using model-based approaches, and being comprehensive in model use. Adopting the MDD will provide positive social change to patients, as human safety improves with better product quality while companies experience fewer product recalls.
APA, Harvard, Vancouver, ISO, and other styles
2

Arredondo, Cecilia. "Imbued Medical Device Design." University of Cincinnati / OhioLINK, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926108.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Lang, Alexandra R. "Medical device design for adolescents." Thesis, University of Nottingham, 2012. http://eprints.nottingham.ac.uk/12501/.

Full text
Abstract:
Adolescents have been identified as users of medical devices who are currently overlooked in the design and development of these products. This research presents a set of studies that investigate the non-clinical user requirements of adolescent medical device users. Interviews with a range of healthcare professionals provided guidance into chronic conditions and devices which are relevant to adolescent populations. Workshops involving healthy adolescents in schools were carried out to elicit adolescent perspectives of current medical device design. The results of this study showed that the range of medical devices presented did not satisfy adolescent user requirements and provided insight into factors which are important to this specific user group. The workshop also identified the acapella® physiotherapy device, used for chest and airway clearance in the treatment of cystic fibrosis, as a suitable case study for further evaluation with real adolescent users. Case study interviews were carried out with adolescents with cystic fibrosis: the users of the acapella®. The interviews identified a range of unmet requirements and expanded on the results from the workshops. In addition to the more general design factors, users of the acapella® highlighted the effect of device use on clinical effectiveness. The data from the workshops and case study interviews was used in a co-design project with an adolescent user of the device. A design specification was interpreted from the data to produce a visual representation of the adolescent requirements. The research has produced two outputs. The first is the development of a prototype tool for eliciting adolescent design priorities for medical devices - The Adolescent Medical Device Assessment Tool (AMDAT) The second deliverable is a set of guidelines which detail the specific requirements and goals of adolescent users of medical devices - Adolescent Medical Device Requirements. This guidance aims to facilitate the consideration of adolescent user requirements in the design and development of new medical devices. The research investigation has contributed new understanding to the fields of human factors and adolescent healthcare. The findings from these studies demonstrate how adolescent populations can be successfully engaged in research tasks. This research investigation has shown that adolescents have specific needs of medical devices and that meeting these needs through user-centred methods may lead to better adherence of use and improved health outcomes.
APA, Harvard, Vancouver, ISO, and other styles
4

Privitera, Mary B. "Collaborative Medical Device Design (cMDD)." Thesis, Loughborough University, 2016. https://dspace.lboro.ac.uk/2134/22524.

Full text
Abstract:
The medical device industry requires multi-disciplinary collaboration between researchers and physicians (Freudenthal et al. 2011). In responding to the challenges associated with medical device development, Ogrodnick (2013) proposed a collaborative model in which design teams have a/synchronous access to a repository of information regarding the progress of the development of a medical device. This research investigates the nature of interactions between manufacturers and physicians throughout the process of medical device development to facilitate more effective practice. A literature review explored the history of medical devices; design and development processes; overall approaches to design and case studies involving healthcare practitioners coupled with collaborative processes. From this detailed review, three gaps in knowledge were identified: industrial design practice in medical device development is not well described; the models and frameworks of user involvement were unverified; user involvement was based on formal agency requirements. Empirical studies were undertaken to identify the state of the art in medical device development and opinions of physician users. These studies were conducted to identify the practices, opinions and influences for collaborative medical device design. The industry study consisted of a multiple case study research design and was used to elicit the practices of 18 major medical device manufacturers. Industry participants were selected on the basis of meeting specific criteria in location, size, type of device manufactured and use of industrial design. Interviews with practicing physicians were conducted to gain insights. The responses from the participants were analyzed using NVivo software, card sorting and data visualization to identify routes to more effective engagement in collaboration during medical device design. The findings indicated that there were seven issues ideas priorities for collaborative practice. These included: user integration throughout the development process; the negotiation/ownership of intellectual property; the knowledge of impact to device design; consistent communication between device developers and physician users; timeliness and efficiencies of interactions; the identification/connection of partners; and meeting legal requirements of healthcare laws. These issues were translated into design requirements and six potential tools for cMDD. Using a Pugh matrix, each concept was evaluated against the developed requirements. As a result, the comprehensive computer application concept, which addressed the maximum number of issues, was selected and further developed for the purposes of validation. The navigation and graphic design was completed and a video, which justified the purpose and explained the software, was produced. To evaluate the concept, seven reviewers consisting of both industry representatives and physicians, whom had no previous knowledge of the research project, evaluated the video with positive responses, further potential uses for the software and suggested improvements. This research concludes that within the current regulated process of development there was flexibility in the application of design control during the conceptual phase and that the majority of developers followed a user driven approach to design. Industrial design was responsible for aesthetic design but limited in impact due to a lack of training in clinical science. Physician users are involved however lack knowledge of development process requirements and their impact. Further that there are barriers to collaboration that prevent consistent and valued interactions. Finally, the research resulted in a confirmed app-based tool that would support the promotion of cMDD.
APA, Harvard, Vancouver, ISO, and other styles
5

Glenn, J. V. "Propionibacterium acnes and medical device infection." Thesis, Queen's University Belfast, 2003. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.273034.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Shefelbine, Sandra J. "Requirements capture for medical device design." Thesis, University of Cambridge, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.287242.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Nair, Ganesh R. "Acquisition of medical device start-ups." Thesis, Massachusetts Institute of Technology, 2006. http://hdl.handle.net/1721.1/37978.

Full text
Abstract:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2006.
Includes bibliographical references (leaf [39]).
Introduction: In the medical device space, a large proportion of the breakthrough inventions are developed by small firms that use private equity to bring their technologies from concept to varying stages of development. Medical Device companies spend a large proportion (11.4 % in 2002) of their sales on R&D, second only to Pharmaceutical companies. Smaller companies, in the meanwhile, spent 343 % of their sales in the same year'. [The Lewin Group (AdvaMed), 2004]. Private Equity financing is a critical factor that enables small start-ups to develop new technologies without a viable revenue stream to support the necessary R&D expenditure. In the medical device space, it has been noted that Venture Capital firms (VC's) use high risk capital to invest in early stage companies, and look for "exits" through either an Initial Public Offering (IPO) or through the sale of the start-up to an established firm. Corporations are also involved in varying degrees in early venture investments, through what is sometimes called Corporate Venture Capital (CVC), mainly for strategic reasons. Through CVC investments, some corporations hope, that as an insider, they would be able to judge better whether a particular company is a good target for acquisition. In this paper I review the exits through acquisition, from the perspective of venture backed start-ups, and hypothesize that factors related to the nature of investors, the type of investment, the impact of capital markets and the Intellectual Property of the company are associated with a higher exit valuation.
Ganesh R. Nair.
S.M.
APA, Harvard, Vancouver, ISO, and other styles
8

Bell, Rory Anthony. "Medical device coatings with enhanced functionality." Thesis, Queen's University Belfast, 2015. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.680887.

Full text
Abstract:
Medical devices are an essential part of the human healthcare system. However, one of the major issues associated with their use is the development of medical device related infections (MDRIs) following bacterial colonisation and subsequent biofilm formation on the surface of the device. Different medical device coatings have been designed to help inhibit biofilm development. Antibacterial coatings include those that are contact active, antibacterial drug eluting or those with altered surface energies. The aim of this research was to develop strategies, which can be used to prevent the initial attachment and proliferation of microorganisms on biomaterial surfaces. Multiple linear regression (MLR) analysis was used to investigate the relationship between various drug physicochemical parameters and drug release from different hydrogel networks, which can be used alone or as a coating on medical devices such as urinary catheters. Models generated from this analysis were capable of accurately predicting the time for specific percentage release of drugs not used to derive the original models. An antibacterial quaternary ammonium compound (QAC) with thiol functionality was covalently immobilised on the surface of PVC. This created an anti-infective surface capable of preventing the adherence of two clinically important pathogens. A series of nature inspired slippery liquid infused porous surfaces were fabricated on the surface of PVC using textured silver coatings infused with different ionic liquids. As well as altering the PVC surface energy microbial adherence studies showed these materials were also capable of reducing, or in some cases preventing bacterial attachment and subsequent biofilm formation. The proposed techniques and materials developed in this thesis could be extremely useful in the fight against MDRIs.
APA, Harvard, Vancouver, ISO, and other styles
9

Wolf, Daniel W. (Daniel William). "Impact of the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct on medical device physician-industry collaboration." Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/58093.

Full text
Abstract:
Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2010.
Cataloged from PDF version of thesis.
Includes bibliographical references (p. 99-102).
The Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct (PCOC) or 105 CMR 970.000 was enacted by the Massachusetts state legislature and adopted by the Department of Public Health (DPH) in July 2009 under Chapter 305 of the Acts of 2008, An Act To Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care. The state law requires pharmaceutical and medical device manufacturers to comply with a marketing code of conduct, obey specific compliance activities, and disclose payments to Massachusetts-licensed healthcare providers with a value of $50 or more in connection with sales and marketing activities. This thesis qualitatively assessed the impact of 105 CMR 970.000 on physician-industry collaboration related to technology development and physician education in the Massachusetts medical device industry, as depicted by academic physicians and representatives of medical device companies during the first quarter of calendar year 2010. A pilot study comprising interviews and surveys of stakeholders in the Massachusetts medical device industry was conducted to summarize the initial impressions of the impact of 105 CMR 970.000 on medical device physician-industry collaboration, with the intention of creating a roadmap for future analysis. Informal interviews (36) included individuals at medical device manufacturers, distributors, academic medical centers, venture capital firms, law firms, consulting firms, MassMedic, and the DPH. Formal surveys (40) included academic physicians and medical device company representatives selling to Massachusetts licensed physicians. The hypothesis was confirmed that 105 CMR 970.000 has impaired medical device physician-industry collaboration related to technology development and physician education in Massachusetts. Our results may have state and federal regulatory implications for the medical device industry and can serve as a guide for future analysis.
by Daniel W. Wolf.
S.M.
APA, Harvard, Vancouver, ISO, and other styles
10

Ward, James R. "Design verification in the medical device industry." Thesis, University of Cambridge, 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.423867.

Full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Books on the topic "Rules of medical device"

1

United States. General Accounting Office. Health, Education, and Human Services Division. Medical devices: FDA review times, 1989 through 1996. Washington, D.C: The Office, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
2

GOVERNMENT, US. An Act to Establish Rules Governing Product Liability Actions against Raw Materials and Bulk Component Suppliers to Medical Device Manufacturers, and for Other Purposes. [Washington, D.C.?: U.S. G.P.O., 1998.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
3

Harnack, Gordon. Mastering and managing the FDA maze: Medical device overview : a training and management desk reference for manufacturers regulated by the Food and Drug Administration. Milwaukee, Wisconsin: ASQ Quality Press, 2014.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
4

Medical device manufacturing. Hauppauge, N.Y: Nova Science Publishers, 2011.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
5

United, States Congress Senate Committee on Health Education Labor and Pensions. Medical devices: Protecting patients and promoting innovation : hearing of the Committee on Health, Education, Labor, and Pensions, United States Senate, One Hundred Twelfth Congress, first session on examining medical devices, focusing on protecting patients and promoting innovation November 15, 2011. Washington: U.S. Government Printing Office, 2014.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
6

Eeckhoven, Eddie F. J. van., ed. Medical device vigilance/monitoring: European device directives compliance. Buffalo Grove, Ill: Interpharm Press, 1997.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
7

United States. Congress. Senate. Special Committee on Aging. A delicate balance: FDA and the reform of the medical device approval process : hearing before the Special Committee on Aging, United States Senate, One Hundred Twelfth Congress, first session, Washington, DC, April 13, 2011. Washington: U.S. G.P.O., 2011.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
8

Zimmerman, Charles S. Pharmaceutical and medical device litigation. [St. Paul, MN]: Thomson/West, 2006.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
9

Montañez, J. Medical device quality assurance manual. Buffalo Grove, IL: Interpharm Press, 1996.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
10

Fries, Richard C. Handbook of medical device design. New York: M. Dekker, 2001.

Find full text
APA, Harvard, Vancouver, ISO, and other styles
More sources

Book chapters on the topic "Rules of medical device"

1

Almpani, Sofia, Petros Stefaneas, Harold Boley, Theodoros Mitsikas, and Panayiotis Frangos. "Computational Regulation of Medical Devices in PSOA RuleML." In Rules and Reasoning, 203–10. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-319-99906-7_13.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Almpani, Sofia, Petros Stefaneas, Harold Boley, Theodoros Mitsikas, and Panayiotis Frangos. "Object-Relational Rules for Medical Devices: Classification and Conformity." In Lecture Notes in Computer Science, 584–91. Cham: Springer International Publishing, 2018. http://dx.doi.org/10.1007/978-3-030-02671-4_37.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Root, Michael J. "Medical Device Batteries medical device battery." In Encyclopedia of Sustainability Science and Technology, 6498–519. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4419-0851-3_658.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Nahler, Gerhard. "medical device." In Dictionary of Pharmaceutical Medicine, 111. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_836.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Root, Michael J. "Medical Device Batteries." In Batteries for Sustainability, 359–92. New York, NY: Springer New York, 2012. http://dx.doi.org/10.1007/978-1-4614-5791-6_11.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Gad, Shayne C., Charles B. Spainhour, and David G. Serota. "Medical Device Development." In Contract Research and Development Organizations-Their History, Selection, and Utilization, 91–108. Cham: Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-43073-3_4.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Gad, Shayne C., and Charles B. Spainhour. "Medical Device Development." In Contract Research and Development Organizations, 39–52. New York, NY: Springer New York, 2011. http://dx.doi.org/10.1007/978-1-4614-0049-3_3.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Nahler, Gerhard. "active medical device." In Dictionary of Pharmaceutical Medicine, 2. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_18.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Khatri, Naresh. "Medical Device Manufacturers." In Crony Capitalism in US Health Care, 82–85. New York: Routledge, 2021. http://dx.doi.org/10.4324/9781003112204-11.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Mantovani, Eugenio, and Pedro Cristobal Bocos. "Are mHealth Apps Safe? The Intended Purpose Rule, Its Shortcomings and the Regulatory Options Under the EU Medical Device Framework." In Human–Computer Interaction Series, 251–75. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-60672-9_12.

Full text
APA, Harvard, Vancouver, ISO, and other styles

Conference papers on the topic "Rules of medical device"

1

Ibrahim, Ilham H., and Constantin Chassapis. "Quantitative Assessment of the Risk of Variations During Medical Device Lifecycle." In ASME 2013 Conference on Frontiers in Medical Devices: Applications of Computer Modeling and Simulation. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/fmd2013-16109.

Full text
Abstract:
The majority of medical devices are monitoring devices. Therefore, data communication and analysis are playing a crucial rule in predicting the effectiveness and reliability of a device. Device related data, patient related data and device-patient related data stored in Data Bases (DBs) are great sources for enhancing either new designs or improving already existing ones. Analyzing such data can provide researchers and device development teams with a complete justification and patterns of interest about a device’s performance, life and reliability. Data can be formulated into stochastic models based their statistical characteristics to consider the variability in data and the uncertainty about processes and procedures during early stages of the design process. This strengthens the device’s ability to function under a broader range of operating conditions. The work herein aims at targeting unwanted variations in device performance during the device development process. It employs a novel technique for variation risk management of device performance based historical process data modeling and visualization. The introduced technique is a proactive systematic procedure comprises a tool set that is being placed in the larger framework of the risk management procedure and fully utilizing data from the DBs to predict and address the risk of variations at the early stages of the design process rather than at the end of each major stage.
APA, Harvard, Vancouver, ISO, and other styles
2

Medina, Lourdes A., Marija Jankovic, and Gül E. Okudan Kremer. "Investigating the Relationship Between Product Design Complexity and FDA for Medical Device Development." In ASME 2013 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/detc2013-13309.

Full text
Abstract:
Product complexity has been studied as an important factor to decrease the cost and time of the development process. With this purpose, prior research has included the development of design complexity metrics as a method to assess and decrease complexity. Recent studies have also focused on the comparison of complexity metrics for the particular case of medical devices development (MDD). However, the major issue relevant to MDD has not been addressed; the relationship between FDA regulations and the device complexity is not clarified. Therefore, to increase MDD safety and decrease the time to market, we must understand the regulatory decision process and rules. In this paper, we investigate the relation between different complexity metrics and FDA’s decision time using a sample of 100 hip replacement devices. Bayesian network learning is used to explore in detail local relationships between different variables, both complexity measures and product variables. This relationship was found significant for the first two clusters of the analysis. However, for a third cluster it is speculated that FDA decision time does not depend solely upon the degree of medical device complexity. Company or organization relevant variables could be playing a greater role than just complexity. Additional questions are drawn based on the results that must be investigated.
APA, Harvard, Vancouver, ISO, and other styles
3

Franke, Stefan, and Thomas Neumuth. "Rule-based medical device adaptation for the digital operating room." In 2015 37th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). IEEE, 2015. http://dx.doi.org/10.1109/embc.2015.7318712.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Manjanatha, Sowmya, Azer Bestavros, Mark Gaynor, and Steve Moulton. "A Rule-Based Decision Framework for Medical Sensor Networks." In 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (HCMDSS-MDPnP 2007). IEEE, 2007. http://dx.doi.org/10.1109/hcmdss-mdpnp.2007.34.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Kim, Jang Hyun, Wooyoung Jeong, and Hyunseok Yang. "Generation of Fuzzy Rules and Learning Algorithms for Servo Control in Holographic Data Storage System." In ASME 2013 Conference on Information Storage and Processing Systems. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/isps2013-2874.

Full text
Abstract:
Today many media of information storage device are formed as disks. Hence, next generation removable data storage media are shaped as disk types too. The holographic data storage system also uses a disk type photopolymer media. And then, holographic data storage system is most advanced optical memory system. Tracking servo and tilt servo control are very important research in holographic data storage system. In this paper, we propose intelligent servo control by fuzzy rules in holographic data storage system. Hence, we have found pattern of tilt servo control in holographic data storage system through fuzzy system. Fuzzy rules were generated by Genetic algorithm for controlling tilt servo. Therefore, we control tilt servo using fuzzy rules in holographic data storage system. Consequently, practical pattern of tilt servo control was found by intelligence algorithm in holographic data storage system.[1]
APA, Harvard, Vancouver, ISO, and other styles
6

Barnett, Ralph L., and James R. Wingfield. "On the Safety of Heating Pads." In ASME 2013 International Mechanical Engineering Congress and Exposition. American Society of Mechanical Engineers, 2013. http://dx.doi.org/10.1115/imece2013-66048.

Full text
Abstract:
The electric heating pad represents one of the medical devices that escaped the FDA safety net by a “grandfather” exemption. An amazing number of philosophical safety issues are introduced by this relatively innocuous commodity. Pain relief is a major attribute of heating pads followed by a minor in actual medical efficacy associated with the improvement of local blood circulation. By contrast, the historic downside is very dramatic featuring electrocution, fire, and skin burns. This paper begins with a brief introduction to current protocol for placing new medical devices into the stream of commerce. In the case of heating pads, it is fortunate that the Underwriters Laboratories Inc. developed and promulgated design rules that effectively mitigated the dangers of shock/electrocution and fire. On the other hand, UL has not undertaken a technical program that addresses the skin burn problem that is the focus of this paper. Nevertheless, many heating pad manufacturers are under the impression that their compliance with UL 130 has ameliorated the skin burn propensity of their pads. Heating pad manufacturers have attempted to control skin burn injuries exclusively through the means of on-product and in-manual warnings that have been promulgated by UL, FDA, and CPSC. This approach has tenaciously maintained a burn rate of 1600 cases per year. A different approach to the skin burn problem is automatically orchestrated by invoking the “Safety Hierarchy.” For example, falling asleep and causing prolonged skin exposures to a heated pad can be eliminated by a dead-man control. Exposure to extreme temperatures that arise when both faces of the pad are concurrently covered is perhaps the most prevalent cause of skin burns. This paper exploits the notion of monitoring both face temperatures and shutting off the pad when they are almost the same. We also explored shutting down the pad when the cycle rate of the bang-bang controls was sufficiently slow; higher heating rates are associated with an uncovered face.
APA, Harvard, Vancouver, ISO, and other styles
7

Almodaifer, Ghada, Alaadin Hafez, and Hassan Mathkour. "Discovering medical association rules from medical datasets." In 2011 International Symposium on Information Technology in Medicine and Education (ITME 2011). IEEE, 2011. http://dx.doi.org/10.1109/itime.2011.6132053.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Regazzoni, Daniele, Andrea Vitali, Caterina Rizzi, and Giorgio Colombo. "A Method to Analyse Generic Human Motion With Low-Cost Mocap Technologies." In ASME 2018 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers, 2018. http://dx.doi.org/10.1115/detc2018-86197.

Full text
Abstract:
A number of pathologies impact on the way a patient can either move or control the movements of the body. Traumas, articulation arthritis or generic orthopedic disease affect the way a person can walk or perform everyday movements; brain or spine issues can lead to a complete or partial impairment, affecting both muscular response and sensitivity. Each of these disorder shares the need of assessing patient’s condition while doing specific tests and exercises or accomplishing everyday life tasks. Moreover, also high-level sport activity may be worth using digital tools to acquire physical performances to be improved. The assessment can be done for several purpose, such as creating a custom physical rehabilitation plan, monitoring improvements or worsening over time, correcting wrong postures or bad habits and, in the sportive domain to optimize effectiveness of gestures or related energy consumption. The paper shows the use of low-cost motion capture techniques to acquire human motion, the transfer of motion data to a digital human model and the extraction of desired information according to each specific medical or sportive purpose. We adopted the well-known and widespread Mocap technology implemented by Microsoft Kinect devices and we used iPisoft tools to perform acquisition and the preliminary data elaboration on the virtual skeleton of the patient. The focus of the paper is on the working method that can be generalized to be adopted in any medical, rehabilitative or sportive condition in which the analysis of the motion is crucial. The acquisition scene can be optimized in terms of size and shape of the working volume and in the number and positioning of sensors. However, the most important and decisive phase consist in the knowledge acquisition and management. For each application and even for each single exercise or tasks a set of evaluation rules and thresholds must be extracted from literature or, more often, directly form experienced personnel. This operation is generally time consuming and require further iterations to be refined, but it is the core to generate an effective metric and to correctly assess patients and athletes performances. Once rules are defined, proper algorithms are defined and implemented to automatically extract only the relevant data in specific time frames to calculate performance indexes. At last, a report is generated according to final user requests and skills.
APA, Harvard, Vancouver, ISO, and other styles
9

Cauchi, Abigail, Harold Thimbleby, Patrick Oladimeji, and Michael Harrison. "Using Medical Device Logs for Improving Medical Device Design." In 2013 IEEE International Conference on Healthcare Informatics (ICHI). IEEE, 2013. http://dx.doi.org/10.1109/ichi.2013.14.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Panescu, D. "Medical device development." In 2009 Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE, 2009. http://dx.doi.org/10.1109/iembs.2009.5333490.

Full text
APA, Harvard, Vancouver, ISO, and other styles

Reports on the topic "Rules of medical device"

1

Smeed, Eric, Willian Van Putte, Guy A. Drew, and Leopoldo Cancio. Special Medical Emergency Evacuation Device Platform. Fort Belvoir, VA: Defense Technical Information Center, October 2002. http://dx.doi.org/10.21236/ada407712.

Full text
APA, Harvard, Vancouver, ISO, and other styles
2

Coleman, M. A. A Handheld Medical Diagnostic Device for Harsh Environments. Office of Scientific and Technical Information (OSTI), November 2019. http://dx.doi.org/10.2172/1574630.

Full text
APA, Harvard, Vancouver, ISO, and other styles
3

Wallace, Dolores R., and D. Richard Kuhn. Software quality lessons from medical device failure data. Gaithersburg, MD: National Institute of Standards and Technology, 1999. http://dx.doi.org/10.6028/nist.ir.6407.

Full text
APA, Harvard, Vancouver, ISO, and other styles
4

Goldman, Julian M., and Susan F. Whitehead. Enabling Medical Device Interoperability for the Integrated Clinical Environment. Fort Belvoir, VA: Defense Technical Information Center, August 2013. http://dx.doi.org/10.21236/ada602056.

Full text
APA, Harvard, Vancouver, ISO, and other styles
5

Thiyagarajan, Magesh. Lightweight Portable Plasma Medical Device - Plasma Engineering Research Lab. Fort Belvoir, VA: Defense Technical Information Center, October 2014. http://dx.doi.org/10.21236/ada611738.

Full text
APA, Harvard, Vancouver, ISO, and other styles
6

Thiyagarajan, Magesh. Light Weight Portable Plasma Medical Device - Plasma Engineering Research Laboratory. Fort Belvoir, VA: Defense Technical Information Center, October 2011. http://dx.doi.org/10.21236/ada611095.

Full text
APA, Harvard, Vancouver, ISO, and other styles
7

Goldman, Julian M., and Susan F. Whitehead. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership. Fort Belvoir, VA: Defense Technical Information Center, October 2012. http://dx.doi.org/10.21236/ada567335.

Full text
APA, Harvard, Vancouver, ISO, and other styles
8

Goldman, Julian M., and Susan F. Whitehead. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership. Fort Belvoir, VA: Defense Technical Information Center, October 2010. http://dx.doi.org/10.21236/ada587842.

Full text
APA, Harvard, Vancouver, ISO, and other styles
9

Goldman, Julian M., and Susan F. Whitehead. Medical Device Plug-and-Play Interoperability Standards & Technology Leadership. Fort Belvoir, VA: Defense Technical Information Center, October 2011. http://dx.doi.org/10.21236/ada554235.

Full text
APA, Harvard, Vancouver, ISO, and other styles
10

Goldman, Julian M., and Susan F. Whitehead. Medical Device Plug-and-Play Interoperability Standards and Technology Leadership. Fort Belvoir, VA: Defense Technical Information Center, October 2013. http://dx.doi.org/10.21236/ada622409.

Full text
APA, Harvard, Vancouver, ISO, and other styles
You might also be interested in the extended bibliographies on the topic 'Rules of medical device' for particular source types:
Journal articles Dissertations / Theses Books
We offer discounts on all premium plans for authors whose works are included in thematic literature selections. Contact us to get a unique promo code!

To the bibliography