ISO 13485 & ISO 9001 Audits for Medical Devices

Who it is for : Quality and regulatory teams at medical device manufacturers and their suppliers, and any organisation preparing an ISO 9001 or ISO 13485 certification, recertification or notified body audit.

What we audit : *ISO 13485 quality management systems for medical devices, including FDA expectations *ISO 9001 quality management systems *Internal audits and supplier audits *Notified body audit preparation *Gap analysis against ISO 13485 or ISO 9001

Audit types : Internal audits, supplier audits, certification readiness audits, gap analysis.

Proof : More than 1,000 audits a year, in France and internationally. 100% delivered on schedule. Conducted to ISO and ICH standards by senior healthcare auditors. Every audit comes with a clear report and a corrective action plan you can act on.

Standards : ISO 13485, ISO 9001, FDA, EU MDR.