Books on the topic 'Medical instruments and apparatus Standards'

Law Library of Congress (U.S.). Global Legal Research Directorate. Approval of medical devices. [Washington, D.C.]: Law Library of Congress, Global Legal Research Center, 2014.

Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

Dills, David. Technical guide: Conducting effective medical device validations. Royal Palm Beach, FL: Institute of Validation Technology, 1999.

Association for the Advancement of Medical Instrumentation. Essential standards for biomedical equipment safety and performance. Arlington, Va: Association for the Advancement of Medical Instrumentation, 1985.

IEE Seminar on Medical Device Standards & Regulations -- All Change (2005 London, England). The IEE Seminar on Medical Device Standards & Regulations -- All Change: 9 March 2005. London: IEE, 2005.

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

Steinborn, Leonard. GMP/ISO Quality Audit Manual for Healthcare Manufacturers: Regulations, Standards, and Guidelines. 6th ed. Hoboken: Informa Healthcare, 2004.

Judy, Strojny, Puleo Joseph, and Center for Devices and Radiological Health (U.S.). Division of Small Manufacturers Assistance, eds. Medical device quality systems manual: A small entity compliance guide. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.

Lowery, Andrew. Medical device quality systems manual: A small entity compliance guide. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1996.

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.

Medical devices: Are current regulations doing enough for patients? : hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Eleventh Congress, first session, June 18, 2009. Washington: U.S. G.P.O., 2012.

Bracey, Alfred. In vitro diagnostic devices: Guidance for the preparation of 510(k) submissions. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1987.

Joseph, Raciti, ed. A practical field guide for ISO 13485: 2003. Milwaukee, Wisconsin: ASQ Quality Press, 2012.

Sidebottom, Charles B. International labeling requirements: For medical devices, medical equipment, and diagnostic products. 2nd ed. Boca Raton, FL: CRC Press, 2003.

Kim, Chŏng-su. Ŭiryo kigi pʻummok pyŏl chŏgyong kyugyŏk hyŏnhwang chosa mit DB kuchʻuk =: The study on the applicable standards to medical devices and building up database for the standards. [Seoul]: Sikpʻum Ŭiyakpʻum Anjŏnchʻŏng, 2007.

Kyper, Charles. Premarket approval (PMA) manual. Rockville, Md: U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Devices and Radiological Health, 1993.

Press, Dyadem, ed. Guidelines for failure modes and effects analysis for medical devices. Boca Raton, FL: CRC Press, 2003.

Kuwahara, Steven S. Quality systems and GMP regulations for device manufacturers: A practical guide to U.S., European, and ISO requirements. Milwaukee, Wis: ASQ Quality Press, 1998.

Association for the Advancement of Medical Instrumentation. Process development and performance qualification for ethylene oxide sterilization--microbiological aspects: Approved 13 March 2000 by Association for the Advancement of Medical Instrumentation. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2000.

Kim, Chi-tʻae. Ŭiryo kigi chejo, suip ŏpso pʻumjil kwalli sisŭtʻem kuchʻuk =: Development of total quality management system for small manufacturers & importers on medical device industry. [Seoul]: Sikpʻum Ŭiyakpʻum Anjŏnchʻŏng, 2007.

Commission, European Pharmacopoeia, ed. European pharmacopoeia. 6th ed. Strasbourg: Council Of Europe, 2007.

Medical device technologies: A systems based overview using engineering standards. [Waltham, MA]: Elsevier/Academic Press, 2012.

Association, Canadian Standards. The ISO 9000 and 13485 essentials: A practical handbook for implementing the ISO 9000 and 13485 standards for medical device manufacturers. 2nd ed. Etobicoke, Ont: Canadian Standards Association, 1998.

Managing the medical arms race: Public policy and medical device innovation. Berkeley: University of California Press, 1992.

Reliable design of medical devices. 3rd ed. Boca Raton: CRC Press, 2013.

F, Booth Anne, ed. Sterilization of medical devices. Buffalo Grove, Ill: Interpharm Press, 1999.

United States. Congress. Senate. Committee on Labor and Human Resources. Classification of Transitional Devices Amendments Act of 1988: Report (to accompany S. 1808). [Washington, D.C.?: U.S. G.P.O., 1988.

Sutton, Charmaine Vercimak. Meeting GMP and ISO 9001 expectations for product development. Waltham, MA: PAREXEL International, 1996.

N.Y.) Medical Packaging Symposium (1998 New York. MPS 98 Medical Packaging Symposium, 98: Proceedings, Medical Packing Symposium, June 1-2, 1998, New York, New York. [S.l.]: Canon Communications, 1998.

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

ISO 13485: A complete guide to quality management in the medical device industry. Boca Raton: Taylor & Francis, 2012.

1948-, Gore Albert, and National Performance Review (U.S.), eds. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

Clinton, Bill. Reinventing regulation of drugs and medical devices. [Washington, D.C.?]: National Performance Review, 1995.

Medical device software verification, validation and compliance. Norwood, Mass: Artech House, 2011.

Six sigma quality design and control. Madison, WI: Westgard QC, Inc., 2001.

Fries, Richard C. Reliable design of medical devices. 2nd ed. Boca Raton, Fl: Taylor & Francis, 2006.

Fries, Richard C. Reliable design of medical devices. 2nd ed. Boca Raton, FL: CRC/Taylor & Francis, 2004.

Medical Devices: Regulations, Standards and Practices. Elsevier Science & Technology, 2015.

Medical Devices: Regulations, Standards and Practices. Elsevier Science & Technology, 2015.

Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Elsevier Science & Technology Books, 2017.

Baura, Gail. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Elsevier Science & Technology, 2020.

Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Elsevier Science & Technology Books, 2020.

Baura, Gail. Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Elsevier Science & Technology Books, 2011.

Institute, American National Standards, and Association for the Advancement of Medical Instrumentation., eds. Medical electrical equipment. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2001.

Institute, American National Standards, and Association for the Advancement of Medical Instrumentation., eds. Medical electrical equipment. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2001.

Institute, American National Standards, and Association for the Advancement of Medical Instrumentation., eds. Medical electrical equipment. Arlington, VA: Association for the Advancement of Medical Instrumentation, 2001.

M, Link David, McDonnell Edward J, and Association for the Advancement of Medical Instrumentation., eds. Current issues on medical device quality systems. Arlington, Va: Association for the Advancement of Medical Instrumentation, 1997.

Kenkyūjo, Sangyō Gijutsu Sōgō, and Japan Keizai Sangyōshō, eds. Jigyō hōkokusho. Ibaraki-ken Tsukuba-shi: Sangyō Gijutsu Sōgō Kenkyūjo, 2007.