Medical devices : FDA should take steps to ensure that high-risk device types are approved through the most stringent premarket review process : report to congressional addressees.

Medical devices : shortcomings in FDA's premarket review, postmarket surveillance, and inspections of device manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2009)

Reinventing regulation of drugs and medical devices.
by: Clinton, Bill, 1946-
Published: (1995)

Medical devices : FDA should expand Its consideration of information security for certain types of devices : report to congressional requesters.
Published: (2012)

Reliable design of medical devices /
by: Fries, Richard C.
Published: (2006)

Medical device safety : the regulation of medical devices for public health and safety /
by: Higson, Gordon R., 1932-2001
Published: (2002)

Medical devices : FDA faces challenges in conducting inspections of foreign manufacturing establishments : testimony before the Subcommittee on Health, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2008)

Medical devices : ISO 13485 and ISO 9001 /
by: Green, G. D. (George Dennis), 1928-
Published: (2005)

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 ... November 15, 2011.
Published: (2014)

Medical devices : status of FDA's program for inspections by accredited organizations : report to congressional committees.
Published: (2007)

Medical devices : status of FDA's program for inspections by accredited organizations : report to Congressional committees /
Published: (2007)

Reliable design of medical devices /
by: Fries, Richard C.
Published: (1997)

Medical devices : Application of risk management to medical devices = Dispositifs médicaux : Application de la gestion des risques aux dispositifs médicaux /
Published: (2019)

Bureau of Medical Devices standards survey /

Bureau of Medical Devices standards survey /
Published: (1982)

Medical device epidemiology and surveillance /
Published: (2007)

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Approval of medical devices.
Published: (2014)

Design controls for the medical device industry /
by: Teixeira, Marie B., 1965-
Published: (2020)

Medical device regulation : too early to assess European system's value as model for FDA : report to the Chairman, Committee on Labor and Human Resources, U.S. Senate /
Published: (1996)

Medical devices : challenges for FDA in conducting manufacturer inspections : testimony before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, House of Representatives /
by: Crosse, Marcia
Published: (2008)

Medical devices : technological innovation and patient/provider perspectives : hearing before the Subcommittee on Health and Environment of the Committee on Commerce, House of Representatives, One Hundred Fifth Congress, first session, May 30, 1997.
Published: (1997)

Medical devices : FDA review time : report to the chairman, Subcommittee on Oversight and Investigations, Committee on Commerce, House of Representatives.
Published: (1995)

Medical devices : guidance on the application of ISO 14971 = Dispositifs médicaux : recommandations relatives à l'application de l'ISO 14971.
Published: (2020)

Medical Device Quality Management Systems : Strategy and Techniques for Improving Efficiency and Effectiveness /
by: Manz, Susanne
Published: (2018)

The FDA medical device user fee program /
by: Johnson, Judith A. (Judith Ann), 1957-
Published: (2020)

The law and regulation of medicines and medical devices /
by: Feldschreiber, Peter
Published: (2021)

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Medical device design : innovation from concept to market /
by: Ogrodnik, Peter J.
Published: (2020)

Medical devices-- quality management systems : requirements for regulatory purposes = Dispositifs médicaux--Systemes de management de la qualité--exigences à des fins réglementaires.
Published: (2016)

Medical Device Cybersecurity for Engineers and Manufacturers, Second Edition.
by: Wirth, Axel
Published: (2024)

Medical devices : hearing before the Committee on Labor and Human Resources, United States Senate, One Hundred First Congress, second session, on examining proposed legislation to revise and strengthen the Food and Drug Administration's regulation of medical devices, July 25, 1990.
Published: (1991)

Medical device regulation : the FDA's neglected child : an oversight report on FDA implementation of the Medical Device Amendments of 1976 : report of the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, U.S. House of Representatives.
Published: (1983)

Guidelines for failure mode and effects analysis for medical devices /
Published: (2003)

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.
Published: (2012)

FDA's clearance of medical devices through the 510(k) process.
Published: (2013)

Premarket assessment of pediatric medical devices.
Published: (2004)