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by Rand Winters, ASR ISO 13485 Auditor (November 2017)

Risk requirements found in ISO 13485:2016 are different from those in the ISO 9001:2015 standard. ISO 13485:2016 has specific risk requirements addressed in......

4.1.5 - outsourced processes

7.1 - product realization Section 7.

7.3.3 - design and development inputs need output from risk management.

7.3.9 - design and development changes - evaluate effect on risk management.
Read more: ISO 13485:2016 – A Risk Management...

What is ISO 13485?

This standard represents the quality and system requirements that medical device manufacturers must incorporate into their management systems.

Like any ISO certification, medical device manufacturers wanting 13485 certification must first learn the requirements of customers and any regulatory agencies, as well as how to implement an ISO 13485 quality management system.
Read more: ISO 13485

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