“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.”
In September 2019, the Association for the Advancement of Medical Instrumentation (AAMI) published a technical information report to smoothen transition for the medical device industry.
The initial goal was, to use ISO 13485 already in April 2019. Now the date has been shifted towards the end of this year as the transition is still in the rule stage.
What are the benefits of the upcoming harmonisation?
Office of Information and Regulatory Affairs: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
Association for the Advancement of Medical Instrumentation: AAMI TIR102:2019
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