EN ISO 13485:2016/AC:2018 PDF
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Title (English):
EN ISO 13485:2016/AC:2018
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
- Document status:
- Active
- Format:
- Electronic (PDF)
- Number of pages:
- 9
- Publication date:
- March 28, 2018
- Edition:
- CEN/CENELEC EN 13485 edition 2 version 1
- ICS:
- 03.100.70
Description (English):
CCMC - creation of a 2nd corrigendum as the instructions in the 1st corrigendum were incomplete and unclear
Technical details
- Technical committee
- CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
- SKU
- EN ISO 13485:2016/AC:2018