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.

Auditing Services Offered

  • ISO 13486:2016
  • Supplier Auditing
  • FDA 21 CFR 820 and ISO Standards

About Prime Path Medtech

We are a team of Medical device experts. We partner with small and mid sized companies at all stages to achieve business outcomes – from strategic regulatory planning to all phases of the product development process to get your product on the market. Along with auditing services, we offer the following services:

Contact us to learn more about auditing services