FDA QMSR, ISO 13485 & EUMDR Compliance Software

FDA QMSR, ISO 13485 & EU MDR ComplianceAdaptive QMS helps regulated organisations navigate the FDA QMSR transition (effective February 2026), ISO 13485:2016 certification, MDSAP multi-jurisdictional audits, and EU MDR/IVDR compliance. Pre-validated platform with built-in audit trails and electronic signature controls.Supported Regulatory Frameworks

FDA QMSR — Quality Management System Regulation 2026

ISO 13485:2016 — Medical Device Quality Management

MDSAP — Multi-jurisdictional single audit programme

EU MDR 2017/745 and IVDR

FDA 21 CFR Part 11 — Electronic Records & Signatures

ISO 9001:2015 including Amendment 1:2024