At some point, every medical device company will encounter an issue that requires an internal investigation. Whether it’s due to a nonconformance, complaint, CAPA, or an audit issue, you’ll have to conduct a failure or root cause investigation to pinpoint why the issue occurred in order to resolve it.

For many companies, the news that they need to conduct an investigation may be accompanied by a sense of dread. It’s never pleasant to think about the implications of anything going wrong with a medical device. But don’t let that put you off the heart of the matter.

An investigation can be an excellent learning mechanism—an opportunity for your business to gain valuable insights that spark process and product improvements that will only serve you better moving forward.

That said, investigations can be confusing for many medical device companies. So, let’s dive deeper into understanding root cause analysis as a high-level concept, what kinds of steps are involved, and the primary methodologies that are used.

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