• Certified ISO13485:2016 Lead Auditor
  • Medical Device / Pharma Quality Management System audits
  • Remote and In-Person audits
  • Audit Plans, Execution, and Reports to meet any budget

expert – sustainable – affordable

Medical Device and Pharmaceutical industry veteran is ready to help you comply with FDA and ISO 13485 requirements through independent audits of your Quality Management System. Serving Medical Device and Pharmaceutical Industries. Quality Management Systems Auditing

Medical Device:

  • ISO 13485:2016
  • US FDA 21 CFR Part 820
  • European MDD / AIMDD / IVDD
  • EU MDR / AIMDR / IVDR
  • ISO 14971 Risk Management¬†

Services:

  • Certified ISO 13485:2016 Lead Auditor
  • Remote and In-Person audits
  • Audit Plans, Execution, and Reports to meet any budget
  • Rapid response to requests for Free Quotes

Pharmaceutical:

  • US FDA Parts 210 & 211
  • ICH Q7 GMP Guide for APIs
  • ICH Q10 Pharmaceutical Quality Systems