AdvQSS Services

Services Offered by Advanced Quality System Solutions:

Quality System Implementation including:

  • 21 CFR Part 820 (FDA Quality System Regulation)
  • ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
  • Canadian Medical Devices Regulation Part 1 (SOR 98/282)
  • ISO 9001:2015, Quality management systems – Requirements
  • COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices (in effect until March 2020)
  • MDR Regulation (EU) 2017/745 (replacing existing Medical Device Directive)

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 actions