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.
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