Knowledge
Clear, current and practical guides on medical device regulation.
FDA / QMSR
FDA QMSR: What Changed on February 2, 2026 and What It Means for Your Internal Audits
The FDA Quality Management System Regulation incorporates ISO 13485:2016 and opens internal audit, supplier audit and management review reports to inspection. What changed and how to prepare.
CE / MDRMDR Classification Rules: A Plain-Language Guide to All 22 Rules
How are medical devices classified under MDR 2017/745 Annex VIII? The differences between Class I, IIa, IIb and III, a summary of all 22 rules and common mistakes.
CE / MDRMDD to MDR Transition: Deadlines, Conditions and Roadmap
The MDR transition periods extended by Regulation 2023/607: which deadline applies to which device, the conditions for the extension and how to plan your transition.
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