ISO 13485-2016 GAP Analysis/QMS Services 

FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid - 2019 and will roll out over the next few years. The industry should begin to perform any relevant gap analyses to prepare for the transition.

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  • ISO 13485-2016 GAP Analysis Services
  • QMS Setup
  • In-house Audits