ISO 13485:2016 – New requirements for the medical devices sector Updating of standards for quality management systems
A shift in focus, divergences and approximations – some fundamental reforms:
- The subchapter “quality manual” has been supplemented with the section “medical device file”, which marks the first time a demand on conformity with international standards and consonance with applicable regulatory requirements was added to the ISO standard.
- The chapters “complaint handling” and “reporting to regulatory authorities” have been expanded and reveal, that the traceability of products is an increasing requirement for medical device companies. It is clearly recognizable that this is an approach towards requirements, which are a fixed component in the pharmaceutical-related quality management since many years.
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