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