Development and use of analytical quality specifications in the in vitro diagnostics medical device industry

Scandinavian Journal of Clinical and Laboratory Investigation

Volumn 59, Issue 7, 1999, Pages 539-543

  Powers, Donald ^a,b   Greenberg, N ^a  

^a Ortho Clinical Diagnostics Inc   (United States)

^b One Wandering Trail   (United States)

Author keywords

Design control; ISO 9001; Performance claims; Performance goals; Quality standards; Quality system; Regulations; Risk analysis; Validation; Verification

Indexed keywords

DEVICE; HEALTH CARE QUALITY; LABORATORY APPARATUS, EQUIPMENT AND SUPPLIES; MEDICAL AUDIT; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW;

EID: 0033388345     PISSN: 00365513     EISSN: None     Source Type: Journal    
DOI: 10.1080/00365519950185319     Document Type: Review

References (16)

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13. 13 ISO 14971-1. Medical devices - risk management - Part 1: Application of risk analysis.
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