FDA ISO QMSR Harmonization

FDA QMSR will make it easier for companies to sell in multiple markets. For the FDA, ISO 13485 harmonization is a way to lessen the burden for medical device companies so they can comply more easily with U.S. regulations and ISO standards.

The changes to 21 CFR Part 820 will mostly be problematic for companies that don’t already follow both U.S. regulations and ISO 13485. Even so, the changes are mostly related to only a few sections of the regulation which are outlined in the FDA’s proposed rule. 

The FDA ISO 13485 harmonization is part of a larger worldwide effort to better align regulatory requirements across countries. These efforts make it easier for medical device companies to comply, which means markets will get access to devices sooner than they otherwise would.

Part of the harmonization process is updating your company’s quality management system, especially the documentation. An eQMS that lets you integrate managing documents, training, quality events, and audits will help you efficiently make changes and ensure nothing slips through the cracks.