Books on the topic 'Medical device safety'

Medical device safety: The regulation of medical devices for public health and safety. Bristol: Institute of Physics Pub., 2002.

Lori, Brown S., Bright Roselie A, and Tavris Dale R, eds. Medical device epidemiology and surveillance. Chichester, West Sussex, England: John Wiley & Sons, 2007.

Boggs & Blow Patton. Guide to medical device regulation. Washington, D.C: Thompson Publishing Group, 1994.

Heller, Mark A. Guide to medical device regulation. Washington, DC: Thompson Pub. Group, 1997.

Heller, Mark A. Guide to medical device regulation. Washington, D.C: Thompson Pub. Group, 1993.

Schoenmakers, C. C. W. CE marking for medical devices: A handbook to the medical devices directives : Medical Device Directive 93/42/EEC : the Active Implantable Medical Device Directive 90/396/EEC. New York, NY: Standards Information Network/IEEE Press, 1997.

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

E, Donawa Maria, ed. International medical device registration. Buffalo Grove, IL: Interpharm Press, 1996.

Medical Device Amendments of 1992. [Washington, D.C.?: U.S. G.P.O., 1992.

Medical device design and regulation. Milwaukee, Wis: ASQ Quality Press, 2011.

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

United States. Food and Drug Administration. FDA device inspections manual. Arlington, VA: Washington Business Information, 1994.

Nippōsha, Yakuji. Guide to medical device registration in Japan. 6th ed. Tokyo: Yakuji Nippo, Ltd., 1997.

Schnoll, Les. The CE mark: Understanding the Medical Device Directive. 2nd ed. Chico, Calif: Paton Professional, 2007.

Association, Health Industry Manufacturers, United States. Food and Drug Administration., Biometric Research Institute, and Device Submissions Workshop (1991 : Arlington, Va.), eds. Medical device submissions handbook: A guide to obtaining FDA approval. Washington, D.C. (1200 G St., N.W., Suite 400, Washington 20005): HIMA, 1991.

Medical device quality assurance and regulatory compliance. New York: Marcel Dekker, Inc., 1998.

US GOVERNMENT. Medical Device User Fee and Modernization Act of 2002. [Washington, D.C: U.S. G.P.O., 2002.

States, United, ed. Shepherd's system for medical device incident investigation & reporting. Brea, CA: Quest Pub. Co., 1992.

El-Haik, Basem. Medical device design for six sigma: A road map for safety and effectiveness. Hoboken, N.J: Wiley-Interscience, 2008.

HIMA Seminar on Medical Device Reporting, One Year Later (1986 Washington, D.C.). HIMA Seminar on Medical Device Reporting, One Year Later: January 23, 1986, Washington, D.C. Washington, D.C. (1030 15th St., N.W., Washington 20005): Health Industry Manufacturers Association, 1986.

FDA inspections: A guide for medical device and diagnostic manufacturers. Buffalo Grove, Ill: Interpharm Press, 1997.

Frank, Sharon. A new model for European medical device regulation: A comparative legal analysis in the EU and the USA. Groningen: Europa Law Pub., 2003.

Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance. Investigational device exemptions manual. Rockville, MD: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.

Food and Drug Law Institute (U.S.), ed. Basic outlines on medical device law and regulation: A collective work by top legal and regulatory experts in the food and drug field. Washington, D.C: Food and Drug Law Institute, 1997.

Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability (2007 Cambridge, Mass.). 2007 Joint Workshop on High Confidence Medical Devices, Software, and Systems and Medical Device Plug-and-Play Interoperability: HCMDSS//MD PnP 2007 : improving patient safety through medical device interoperability and high confidence software : proceedings : 25-27 June 2007, Cambridge, Massachusetts. Piscataway, N.J: IEEE, 2007.

Medical device safety: How FDA regulates the reprocessing of supposedly single-use devices : hearing before the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, second session, September 26, 2006. Washington: U.S. G.P.O., 2006.

Device Submissions Workshop (4th 1994 Arlington, Va.). Straight talk from the FDA about submissions: Remarks of ODE Division Directors at the 1994 HIMA Device Submissions Workshop, July 18, 1994, Arlington, Virginia. Washington, D.C. (1200 G St., N.W., Suite 400, Washington 20005-3814): Health Industry Manufacturers Association, 1994.

United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment. Medical device safety: Hearings before the Subcommittee on Health and the Environment of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress on H.R. 3095 ... November 6, 1989 and July 17, 1990. Washington: U.S. G.P.O., 1990.

New model for european medical device regulation: A comparative legal analysis in the eu and the usa. [Place of publication not identified]: Europa Law Publishing, 2003.

Weinberg, Sandy. Cost-contained regulatory compliance: For the pharmaceutical, biologics, and medical device industries. Hoboken, N.J: John Wiley & Sons, 2011.

Medical Device User Fee and Modernization Act of 2002: Report (to accompany H.R. 3580). [Washington, D.C: U.S. G.P.O., 2002.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee and Modernization Act of 2002: Report (to accompany H.R. 3580). [Washington, D.C: U.S. G.P.O., 2002.

Medical devices and the public's health: The FDA 510(k) clearance process at 35 years. Washington, D.C: National Academies Press, 2011.

Medical Device User Fee and Modernization Act of 2002: Supplemental report (to accompany H.R. 3580). [Washington, D.C.?: U.S. G.P.O., 2002.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee and Modernization Act of 2002: Supplemental report (to accompany H.R. 3580). [Washington, D.C.?: U.S. G.P.O., 2002.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee and Modernization Act of 2002: Supplemental report (to accompany H.R. 3580). [Washington, D.C.?: U.S. G.P.O., 2002.

Practical guide to GMPs for device and diagnostic manufacturers: 21 CFR 820, effective June 1997 : EN 46000, ISO 9000. Buffalo Grove, IL: Interpharm Press, 1997.

United States. Congress. Senate. A bill to amend the Federal Food, Drug, and Cosmetic Act to require any person who reprocesses a medical device to comply with certain safety requirements, and for other purposes. Washington, D.C: U.S. G.P.O., 1999.

United States. Congress. House. Committee on Energy and Commerce. Food, Drug, Cosmetic, and Device Safety Amendments of 1992: Report together with dissenting views (to accompany H.R. 3642) (including cost estimate of the Congressional Budget Office). [Washington, D.C.?: U.S. G.P.O., 1992.

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.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee Act of 1994: Report together with dissenting and additional views (to accompany H.R. 4864) (including cost estimate of the Congressional Budget Office). [Washington, D.C.?: U.S. G.P.O., 1994.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee Act of 1994: Report together with dissenting and additional views (to accompany H.R. 4864) (including cost estimate of the Congressional Budget Office). [Washington, D.C.?: U.S. G.P.O., 1994.

United States. Congress. House. Committee on Energy and Commerce. Medical Device User Fee Act of 1994: Report together with dissenting and additional views (to accompany H.R. 4864) (including cost estimate of the Congressional Budget Office). [Washington, D.C.?: U.S. G.P.O., 1994.

Investigations, United States Congress House Committee on Energy and Commerce Subcommittee on Oversight and. The Bjork-Shiley heart valve, earn as you learn: Shiley Inc.'s breach of the honor system and FDA's failure in medical device regulation : a staff report. Washington: U.S. G.P.O., 1990.

United States. General Accounting Office., ed. Medical device recalls: Examination of selected cases : report to the chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives. Washington, D.C: The Office, 1989.

The impact of medical device and drug regulation on innovation, jobs, and patients: A local perspective : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Twelfth Congress, first session, September 26, 2011. Washington: U.S. G.P.O., 2012.

FDA medical device approval: Is there a better way? : hearing before the Subcommittee on Health Care, District of Columbia, Census, and the National Archives of the Committee on Oversight and Government Reform, House of Representatives, One Hundred Twelfth Congress, first session, June 2, 2011. Washington: U.S. G.P.O., 2011.

Safety evaluation of medical devices. New York: Marcel Dekker, 1997.

Higson, G. R., and Gordon Higson. Medical Device Safety. Taylor & Francis Group, 2010.

Higson, G. R. Medical Device Safety: The Regulation of Medical Devices for Public Health and Safety. Taylor & Francis Group, 2001.