Design Control Requirements for Medical Device Development

World Journal for Pediatric and Congenital Heart Surgery

Volumn 3, Issue 1, 2012, Pages 77-81

  Kinsel, David ^a  

^a Terumo Cardiovascular Systems   (United States)

Author keywords

collaboration; device; regulations; requirements

Indexed keywords

EID: 84990328184     PISSN: 21501351     EISSN: 21500136     Source Type: Journal    
DOI: 10.1177/2150135111422720     Document Type: Review

References (4)

1. US Food and Drug Administration. Title 21: Food and Drugs. Chapter I: Food and Drug Administration, Department of Health and Human Services. Subchapter H: Medical Devices. 21CFR part 820: Quality System Regulation. 1996.
2. Center for Devices and Radiological Health. FDA Design Control Guidance for Medical Device Manufacturers. US Food and Drug Administration; 1997.
3. International Organization for Standardization. Medical Devices—Quality Management Systems—Requirements for Regulatory Purposes (ISO 13485). International Organization for Standardization; 2003.
4. Medical Device Manufacturers Association. FDA Impact on U.S. Medical Technology Innovation. Medical Device Manufacturers Association; 2010: 22–23. http://www.medicaldevices.org/node/846. Accessed November 18, 2010.