MDSAP, ISO 13485:2016, 21 CFR 820, Medical Device Regulation Audits

Why perform Quality Audits?

  • Quality Audits are required by regulation
  • They identify systemic gaps in regulatory compliance
  • Causes of poor product quality may be identified
  • Audits may be leveraged to identify process improvement and cost reduction opportunities

One audit we conducted identified unnecessary inspections at incoming inspection, redundant in-process inspections, and unnecessary device history record reviews. Our recommended savings were in the tens of thousands of dollars per year.


We have certified13485:2016 auditor training  and over 20 years auditing experience.

Medical Device Auditing Services:

  • Gap analysis audit
  • Pre-assessment audit
  • FDA inspection – Assist during an actual FDA inspection by managing the “back room”, taking minutes, or interfacing with FDA.
  • Mock audits to train employees
  • Full or partial internal audit
  • Subcontractor or supplier audit