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AdvQSS Services

Quality System Implementation including:

Gap analysis/transition plans for:

  • ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO 9001:2015, Quality management systems – Requirements
  • Regulation (EU) 2017/745 (replacing existing Medical Device Directive)
  • Internal Quality System Audits
  • Supplier Audits
  • Review quality system documentation
  • Quality System Training
  • MDSAP (Medical Device Single Audit Program) overview and preparation
  • On-site support during FDA inspections/registrar audits
  • FDA 483 and Warning Letter responses and follow up action