Quality System Implementation including:
- 21 CFR Part 820 (FDA Quality System Regulation)
- 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
- 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
MDSAP (Medical Device Single Audit Program) overview and preparation
On-site support during FDA inspections/registrar audits
Ongoing Quality Assurance Support
FDA 483 and Warning Letter responses and follow up actions