Latest Blog Posts
Navigating MDR: Fresh Insights and Updates
Meet the Team: Maurice Veerkamp
At MedQAIR, our work sits at the intersection of regulatory expertise, quality systems, and digital innovation. Supporting manufacturers of Software as a Medical Device (SaMD),
FDA’s New QMSR Rule: Aligning 21 CFR 820 with ISO 13485:2016
In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part 820 to incorporate ISO 13485:2016
Navigating UDI: GUDID vs EUDAMED, and How MDIS Helps You Comply
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems have been adopted worldwide to
Meet the Team: Trudy Kunnen
At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of experience, perspective, and commitment to
Meet the Team: Mike Graney
At MedQAIR, we combine regulatory expertise with a passion for building bridges, connecting continents, linking innovators with compliance, and uniting people who share deep industry
Medical Device Authorised Representatives and Importers and The Use of MDIS
Navigating post-market compliance under MDR/IVDR has never been more complex. As regulatory demands rise, responsibility no longer rests solely with the manufacturer, it extends across
Regulatory Challenges for Medical Device Distributors in the EU
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers and Authorised Representatives of medical
The Compliance Gap: What Happens When Economic Operators Don’t Coordinate
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are distributed across various economic operators
MDCG 2025-5: New Q&A Clarifies Rules for IVD Performance Studies Under the IVDR
On June 18, 2025, the EU Medical Device Coordination Group (MDCG) released MDCG 2025-5, a detailed Q&A document clarifying the rules for in vitro diagnostic
