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Category: ISO 13485

All AQAP BRC CRA DPD EN 1090/ISO 3834 EUDR Food FSC FSSC 22000 GLOBAL G.A.P. GMP+ HACCP IFS ISO 13485 ISO 14001 ISO 17025 ISO 22000 ISO 22301 ISO 22716 ISO 27001 ISO 27002 ISO 27017 ISO 27018 ISO 28000 ISO 31000 ISO 42001 ISO 45001 ISO 50001 ISO 9001 KZR NIS 2 PEFC PPWR TISAX
ISO 13485 and the MDR – how does the standard support compliance with EU medical device legislation?

ISO 13485 and the MDR – how does the standard support compliance with EU medical device legislation?

Regulation (EU) 2017/745 of the European Parliament and of the Council – commonly known as the MDR – has been in force since 26 May 2021 and replaced the previous Directive 93/42/EEC. read more Key requirements of ISO 13485 – what sets it apart from ISO 9001?

Key requirements of ISO 13485 – what sets it apart from ISO 9001?

Companies holding ISO 9001 certification that are entering the medical devices sector or expanding their operations into this sector often assume that ISO 13485 certification will simply complement their existing system. read more ISO 13485 – a quality management system designed for the medical devices industry

ISO 13485 – a quality management system designed for the medical devices industry

The medical devices industry is one of the most heavily regulated industrial sectors in the world. read more
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