ISO 13485 QMS requirements and FDA’s QSR to Merge.
Medical device companies need to be adept at negotiating different regional regulatory requirements. They have become accustomed to the complexities surrounding varying requirements and establishing processes to cope.
It had been suspected, given the changes introduced in the 2016 version of ISO 13485, that harmonisation with US requirements was at the front of the technical committees mind.
The new version of the standard shunned Annex SL, applied in the new version of ISO 9001:2015, in favour of the existing standard format.
FDA press officer Stephanie Caccomo is reported as stating: “With the publishing of the ISO13485:2016 revision, there has been industry evaluation of the regulatory requirement linkages to the standard. In the spirit of global harmonization of quality management systems, the FDA is considering an evaluation/mapping of the 13485 clauses to the appropriate U.S. regulatory requirements.”
This is a welcome development for the medical device industry, simplifying the requirements for quality management systems.
For once, things might get a little simpler.