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Publication

FDA Quality System Regulation

FDA Quality System Regulation - 21 CFR Part 820
Edition 2023-08

Standards [CURRENT]

DIN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
Edition 2021-12

Standards [CURRENT]

DIN EN ISO 16571

Systems for evacuation of plume generated by medical devices (ISO 16571:2024); German version EN ISO 16571:2024
Edition 2024-09

Draft standard

DIN EN ISO 16571/A1

Systems for evacuation of plume generated by medical devices - Amendment 1 (ISO 16571:2024/DAM 1:2025); German and English version EN ISO 16571:2024/prA1:2025
Edition 2025-06

Standards [CURRENT]

DIN EN ISO 12417-1

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2024); German version EN ISO 12417-1:2024
Edition 2024-08

Standards [CURRENT]

SN EN ISO 13485

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Edition 2016-03

Standards [CURRENT]

SN EN ISO 13485/AC

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Corrigendum AC
Edition 2020-04

Standards [CURRENT]

SN EN ISO 13485/A11

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); Amendment A11
Edition 2021-11

Standards [CURRENT]

BS EN ISO 13485+A11

Medical devices. Quality management systems. Requirements for regulatory purposes
Edition 2016-02-29

Standards [CURRENT]

NF S99-101 ; NF EN ISO 13485:2016-04-30

Medical devices - Quality management systems - Requirements for regulatory purposes
Edition 2016-04-30

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