Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going on once a medical device has reached the market, and it can be challenging to keep up with requirements of post-market surveillance and any implications for your risk management. There’s often some confusion, too: How exactly do you integrate complaint handling and your risk management procedures?

Complaint handling overview

Any complaint handling happens after your device has been launched into the marketplace. As the only quality process you have where you directly interact with the customer, it is a unique task for companies to handle.

Historically, the FDA has focused on ensuring processes and procedures are in place to handle complaints. An extreme case is if the complaint did lead, or could have led, to serious injury or death, then the FDA’s Medical Device Reporting (MDR) regulation kicks in, and the complaint becomes a reportable event.

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