​From MedTech Innovation to Compliant Market Access.                                     

The EU draft implementing act December 2025 focuses on harmonising notified body procedures across the EU. This harmonisation addresses long-standing concerns about inconsistent practices that affect manufacturers’ ability to plan and budget for certification. Key Areas Covered Key areas covered include: Uniform requirements for notified bodies to ensure all operate under the same standards. Clear notified body procedural requirements that define how conformity assessments sh

The FDA QMSR final rule January 2024 introduces a modernized framework for medical device quality management system requirements 2026. This update replaces the older 21 CFR Part 820 QMSR, which has been the foundation of US medical device quality regulations for decades. The new regulation emphasizes risk-based approaches, harmonization with global standards, and enhanced post-market surveillance. Why the Transition from QSR to QMSR Matters The transition from QSR to QMSR ref