The FDA requires medical devices to comply with rigorous manufacturing standards. Noncompliant devices can be subjected to additional testing or verification, which can be costly in terms of both time and money. Our medical device auditing services give you the peace of mind that your device complies with all necessary regulations.

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. If any such opportunities exist for your business, rest assured that we will find them.

Vision28’s medical device auditing services guarantee that your medical device will comply with all FDA and ISO regulations and standards. We have the experience and training to perform medical device audits that identify areas for improvement and potential savings.

We have certified 13485:2016 auditor training and over 20 years of auditing experience.

Our Medical Device Auditing Services will assess the following areas:

  • 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

Contact us at your earliest convenience to learn about our medical device auditing services and how they can benefit your business. We will be happy to walk you through our auditing services and outline how they can help you.