Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485 outlines the guidelines for medical device quality management systems. ISO 13485:2016 has been adopted by regulatory agencies around the world as a universally harmonized standard.

However, the International Organization for Standardization itself is not a governing regulatory agency; unlike government agencies, ISO does not publish reports to the public of violations during audit findings. This fact makes it nearly impossible for device makers in this market to research and learn from others’ mistakes.

With more than 20 years of experience working in the medical device industry, I’ve seen my fair share of mistakes made during ISO 13485 implementation, with six mistakes in particular that commonly trip up device makers. You can learn from these missteps of others and avoid making them yourself:

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