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Certification
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
International Organization for Standardization (ISO)
Certification
EN ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
International Organization for Standardization (ISO)
Certification
93/42/EEC Annex II
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
Emergo: Global Medical Device Consulting