Auditing Service – Prime Path MedTech

Friendly Auditors, Friendly Pricing

Do you need an internal audit, but are dreading the findings and the work that comes after?

We can perform FDA and ISO 13485:2016 audits for Gap or internal requirements, supplier audits, MDSAP (Gap Assessment Audits) and we can also provide support during a regulatory audit.

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
MDSAP
Auditing
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:

Friendly Auditors, Friendly Pricing

Do you need an internal audit, but are dreading the findings and the work that comes after?

Auditing Services Offered

About Prime Path Medtech

Contact us to learn more about auditing services