Implementing the new Quality System requirements: Design controls

Biomedical Instrumentation and Technology

Volumn 31, Issue 2, 1997, Pages 119-127

  Stoeger, Kenneth J ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

LAWS AND LEGISLATION; PRODUCTION CONTROL; QUALITY ASSURANCE; QUALITY CONTROL; SPECIFICATIONS; STANDARDS;

DEVICE DESIGN CONTROL REQUIREMENTS; QUALITY SYSTEM REGULATION;

BIOMEDICAL EQUIPMENT;

BIOMEDICAL ENGINEERING; DEVICE; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; SAFETY; STANDARD; VALIDATION PROCESS;

EQUIPMENT AND SUPPLIES; EQUIPMENT DESIGN; HUMANS; INTERNATIONAL COOPERATION; QUALITY ASSURANCE, HEALTH CARE; QUALITY CONTROL; RISK ASSESSMENT; SOCIAL RESPONSIBILITY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031106264     PISSN: 08998205     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (6)

1. Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation, FDA, October 1996.
2. Design Control Guidance for Medical Device Manufacturers. FDA, March 1996.
3. Preproduction Quality Assurance Planning: Recommendations for Medical Device Manufacturers. HHS publication FDA 90-4236. Rockville, MD, FDA, 1989.
4. Stoeger KJ. Design assurance principles for the medical device industries, Chicago: Interpharm Press, Inc., 1989.
5. Design Control. Medical Device and Diagnostic Industry Reprint Series. Canon Communication, Inc., 1994.
6. Do It By Design: An Introduction to Human Factors in Medical Devices. HHS draft publication, March 1, 1996.