Compliant Quality Systems prevent costly interruption of your business flow due to unfavorable regulatory 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.
FDA 21 CFR § 820, ISO 13485, and Canadian Medical Device Regulations (CMDR).
We have certified13485:2016 auditor training and over 20 years auditing experience.
Medical Device Auditing Services:
Gap analysis audit
FDA inspection – Assist during an actual FDA inspection by managing the “back room”, taking minutes, or interfacing with FDA.