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Books on the topic 'Rules of medical device'

Author: Grafiati

Published: 4 June 2021

Last updated: 3 February 2022

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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.

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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.

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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.

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4

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

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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.

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6

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

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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.

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8

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

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9

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

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10

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

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11

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

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12

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

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13

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

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14

Gonzalez, J. Crusat. Medical drip rate measurement device. Manchester: UMIST, 1995.

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15

World Health Organization (WHO). Development of medical device policies. Geneva, Switzerland: World Health Organization, 2011.

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16

Brown, S. Lori, Roselie A. Bright, and Dale R. Tavris, eds. Medical Device Epidemiology and Surveillance. Chichester, UK: John Wiley & Sons, Ltd, 2007. http://dx.doi.org/10.1002/9780470060872.

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17

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

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18

Boozang, Kathleen M., and Simone Handler-Hutchinson. Pharmaceutical and medical device compliance manual. Washington, DC: American Health Lawyers Association, 2012.

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19

The medical device R & D handbook. 2nd ed. Boca Raton: Taylor & Francis, 2013.

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20

David, Hutchinson, and Joris Bannenberg. 12 Golden ISO14155 Rules for Medical Device Trials. Canary Publications, 2005.

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21

Medical device tracking: Questions and answers based on the final rule (Medical devices). For sale by the U.S. G.P.O., Supt. of Docs, 1993.

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22

Sharp, John. Quality Rules in Medical Device Manufacture: Revised American Edition (5-pack). Informa Healthcare, 2002.

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23

Medical devices: European Union's regulatory process. Washington, D.C. (P.O. Box 37050, Washington, D.C. 20013): The Office, 1997.

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24

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. ASQ Quality Press, 1999.

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25

Medical Device Register (Medical Device Register (United States)). 2nd ed. Sedgwick Press, 2008.

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26

Medical Device Sterilization. Technomic Publishing Co, 1996.

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27

Medical Device Strategies. Urch Publishing Ltd, 1997.

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28

(Editor), Stephen A. Mariano, and Robert Farra (Editor), eds. Medical Device Assembly. CRC, 2007.

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29

Medical Device Technologies. Elsevier, 2021. http://dx.doi.org/10.1016/c2016-0-00190-0.

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30

Medical Device Design. Elsevier, 2013. http://dx.doi.org/10.1016/c2011-0-04144-3.

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31

Medical Device Technologies. Elsevier, 2012. http://dx.doi.org/10.1016/c2009-0-20222-4.

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32

Medical Device Design. Elsevier, 2020. http://dx.doi.org/10.1016/c2016-0-05027-1.

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33

Medical Device Sterilisation. Technomic Publishing Co, 2000.

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34

Sifton, David W. Medical Device Register 1996 (Medical Device Register International Volume). Thomson P D R, 1996.

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35

Garrett, Heidi Siegenthaler. Medical Device Register, 1989: International (Medical Device Register International Volume). Medical Device Register, 1989.

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36

Medical Device Register, 1990: International (Medical Device Register International Volume). Medical Device Register, 1990.

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37

Medical Device Register, 1993: International (Medical Device Register, International Edition). Thomson Healthcare, 1993.

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38

J, Pisano Douglas, and Mantus David, eds. FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2nd ed. New York: Informa Healthcare USA, 2008.

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39

J, Pisano Douglas, and Mantus David, eds. FDA regulatory affairs: A guide for prescription drugs, medical devices, and biologics. 2nd ed. New York: Informa Healthcare USA, 2008.

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40

Preventing Medical Device Recalls. Taylor & Francis Group, 2014.

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41

Medical Device Register, 1992. Thomson Healthcare, 1992.

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42

1944-, O'Brien Joseph D., ed. Medical device packaging handbook. New York: M. Dekker, 1990.

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43

Economics, Medical. Medical Device Register, Supplement. Medical Economics Company, 1994.

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44

1931-, Sherman Max, ed. Medical device packaging handbook. 2nd ed. New York: Marcel Dekker, 1998.

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45

1999 medical device register. Montvale, N.J: Medical Economics, 1999.

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46

Canada. Biotechnology and Health Care Products Directorate., ed. Canadian medical device directory. [Ottawa]: Biotechnology and Health Care Products Directorate, Department of Regional Industrial Expansion, 1988.

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47

Allen, Amy. Medical Device Industry Factbook. 3rd ed. Canon Communications, LLC, 1996.

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48

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

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49

Farb, Daniel. Powerful Medical Device Sales. UniversityOfHealthCare, 2005.

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50

Wiklund, Michael, Andrea Dwyer, and Erin Davis. Medical Device Use Error. CRC Press, 2016. http://dx.doi.org/10.1201/b19265.

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