Medical Device Audits

The medical device industry is highly regulated and various audits are necessary. Our auditors are friendly, have real world experience and can help provide practical suggestions.

The stakes are high as the complexity of regulations worldwide only grows more and more each year. It is easy to become over burdened and miss a key requirement. Auditing your medical devices against these requirements is necessary to make sure your team is in compliance.

AUDITING SERVICES OFFERED

ISO 13485:2016

FDA 21 CFR 820

Supplier Audits

MDSAP Audits

WHY CHOOSE US?

Because our “day job” is managing quality and regulatory systems for companies, it gives us a unique view on how to comply with the regulations, without destroying your innovative nature with bureaucracy and paperwork.

  • Our medical device auditing team has the experience of many FDA, ISO, and other certification audits under their belt. In addition, our audit team has real world and current experience.
  • We don’t just audit, our team manages quality systems every single day as part of their job to stay current with the regulations and the real world implementation of the regulations.
  • The difference between us and other 3rd party auditors is our current, real world experience. In other auditing organizations, their audits only really do audits and never really have to work using their “suggestions” on a daily basis
  • With our team, you know we actually successfully use our “suggestions” every day and our team has to handle multiple FDA and ISO audits every year. This keeps our knowledge and practice current. And we can pass on this experience to you and your team.
  • Most importantly, our auditors are on your side and are there to help in a friendly manner
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Prime Path Medtech considers it our responsibility to make the audit process as seamless as possible. Learn how we can bring your medical device quality system into compliance.

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