Medical Device

EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests …

EU MDR 2017/745 Compliance Assessment

Evaluate compliance with European Medical Device Regulation 2017/745 covering device classification, quality management, clinical evaluation, …

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

ISO 13485:2016 QMS Assessment

Evaluate compliance with ISO 13485:2016 Quality Management System requirements for medical device design, development, production, and servicing

MDSAP Readiness Assessment

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit

UDI Compliance Assessment (FDA & EU)

Evaluate Unique Device Identification compliance for FDA (21 CFR Part 801/830) and EU MDR (Article 27), covering UDI assignment, labeling, …