The quality management guidelines set forth by the FDA and ISO have been put in place to help ensure that the end users of medical devices can benefit from a device that is both safe and effective. Simultaneously, the guidelines protect manufacturers by helping them establish a system that produces safe and effective medical devices that can be sold around the world. The FDA and ISO require medical device manufacturers to establish protocols for dealing with instances of non-conforming devices, ensuring that the devices are not mistakenly sold to the public and that manufacturers diligently identify and investigate the root cause of any non-conformance issues that arise.
In 21 CFR Part 820.90, the FDA gives the regulations for how medical device manufacturers should deal with instances of non-conforming product:
Once a manufacturer has followed the FDA-mandated process for nonconformance management, they may be able to dispose of the material at their discretion. Manufacturers have several options for how to deal with non-conforming materials, parts or products:
Whichever route is chosen, the manufacturer must ensure that documentation is created to describe and justify the action that was taken, along with the documents that describe the evaluation and investigation process.
When an instance of non-conformance is identified as part of an internal quality
Manufacturers can undertake a root cause analysis and initiate their CAPA procedure to identify and correct the underlying causes of an identified nonconformance issue.
When the FDA audits your medical device company (and they will), you will need to show that you have taken steps to identify instances of non-conforming product, conducted evaluations and investigations in relation to those identifications, and that someone reviewed those materials and authorized a particular course of action for dealing with each non-conformance event.
Greenlight Guru's Quality Management Software helps manage and control your medical device company's documentation in compliance with FDA and ISO guidelines for nonconformance management. You'll also benefit from an electronically-accessed nonconformance management system that's closely connected with your CAPA process, ensuring that you’re able to focus on achieving True Quality even when you have a non-conforming event.
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