Staying on the compliant side of change control regulations

Proper change control is essential to ensure the quality and safety of medical devices. [Photo courtesy of MasterControl]

Medical device change control regulations have a lot of boxes to check.

By Matt Lowe, MasterControl

Given the dynamic nature of medical device development, changes are inevitable.

Change control focuses on managing changes throughout a product’s life cycle as a part of current good manufacturing practices (cGMP). Extensive regulations ensure that changes don’t put the safety, reliability and performance of products at risk. Therefore, it’s critical that medical device manufacturers adhere to all of the regulatory change control guidelines.

This article provides four tips for effectively managing change control to remain compliant with cGMP regulations.

1. Know that regulatory changes are coming

The FDA is close to aligning the current cGMP requirements of its Quality…

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