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- ISO13485 In Vitro Diagnostic/ Medical Devices
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- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
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Medical Devices FDA
[FDA] QSR(QUALITY SYSTEM REGULATION)
- Admin Hits:547
- 2017-05-26 19:25:00
FDA QSR(QUALITY SYSTEM REGULATION)이란?
현재 미국의 FDA 품질시스템 규정을 말합니다.
1997년 이전까지는 cGMP(current Good Manufacturing Practice)로 사용 되었습니다.
FDA에 이미 시판 전 의료기기 등록 510(k)를 하였거나
시판 전 의료기기 허가(PMA)를 진행하는 경우 21CER 820 QSR에 따라 FDA로 심사를 받게 됩니다.
하기 링크를 통하여 21CER 820 를 확인해 보시기 바랍니다.
관련링크 : https://www.accessdata.fda.gov/script-x-xs/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820
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