Source: office of information and regulatory affairs
FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.
- Forums
- ASX - By Stock
- RAP
- Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485
Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-44
-
-
- There are more pages in this discussion • 34 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)