Auditing Services

Auditing Services

About

At Fiunex, we understand the critical importance of maintaining a robust quality management system (QMS) for your organization.

One of the key tools in ensuring the effectiveness and compliance of your QMS is internal audits. Our Internal Auditing Services are designed to help you identify areas within your quality management system that require improvement, offering you a comprehensive evaluation of its gaps and effectiveness.

Services

Services

Auditing Services

Medical Device Single Audit Program (MDSAP) Audits

21 CFR Part 820 / 210 / 211 Audits

ISO 13485 and ISO 9001 Audits

European Medical Device Regulation (MDR) and European IVDR Audits

Standards / Auditor Training