News
Press Review
CSDmed in *Le Figaro*: R&D, Quality, and Regulatory Affairs in the Medical Device Industry
Medical devices regulation
MDCG 2026-4: why manufacturers are becoming the managers of SS(C)Ps in EUDAMED
Medical devices regulation
EUDAMED: Four modules are now operational. Why this development is already changing the obligations of medical device manufacturers
Medical devices regulation
Borderline Manual v5: What Are the New Qualification and Classification Scenarios Under the MDR and IVDR?
News
Fitness for use and risk management: how a manufacturer of motorized dental instruments secured its CE/FDA file thanks to an integrated approach
News
MDR harmonized standards published in January 2026: what manufacturers really need to look at
News
How long does an EUDAMED recording really take?
Medical devices regulation
Post-market surveillance (PMS) under MDR and IVDR: what the MDCG 2025-10 guide really changes for manufacturers
News
The European Commission wants to simplify MDR and IVDR: what do manufacturers really need to understand?
Medical devices regulation
Breakthrough Devices (BtX): what does MDCG 2025-9 really change for medical device manufacturers?
Medical devices regulation
Eudamed really becomes operational: what Decision (EU) 2025/2371 changes for medical device manufacturers
Medical devices regulation
Clinics under the MDR: how to navigate between clinical evaluation, clinical investigation and applicable standards?
Medical devices regulation
MDCG 2025-8: how should optics manufacturers manage the Master UDI-DI?
News
MDR: what does the transfer agreement published by Team-NB really change?
News
Pilot coordinated assessment for CI/PS: a new step towards European coordinated assessment of clinical studies
News
MedTech start-ups: how to get a CE marking project off to a good start?
Medical devices regulation
Biocompatibility and start-ups: how not to get lost in BEP, BER and TRA?
News
ISO 13485 for start-ups: 3 realistic approaches
Medical devices regulation