Medical devices regulation
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
Version 4 of the EU Borderline & Classification Manual: What Manufacturers Need to Know (September 2025)
Medical devices regulation
Submission of the IVDR Technical File: What Manufacturers Really Need to Get Right (Team‑NB, Sept. 2025)
Medical devices regulation
Combination products: bridges between ISO 13485 and ISO 15378 (and what the authorities expect)
News
FDA vs MDR: 5 differences that matter to DM manufacturers
News
IVDR and IVD Software: How to Properly Qualify and Classify Your Software
News
CECP Procedure: What Should Medical Device Manufacturers Watch Out For?
Medical devices regulation
MDCG 2019-11 rev.1: What the New Version Changes for medical and IVD Software
Medical devices regulation
New MDCG 2025-4 Guidance: Requirements for Medical Device Software Apps on Online Platforms
News
MDR CE marking: pitfalls to avoid as a start-up
Medical devices regulation
EUDAMED: Upcoming Obligations for Medical Device Manufacturers
News
ISO 14971 and start-ups: how to get started on risk analysis without getting lost
Medical devices regulation
EUDAMED: which players (really) need to register? Deciphering the MDCG 2021-13 guide
Medical devices regulation
MIR Form v7.3.1: what manufacturers need to anticipate before November 2025
Medical devices regulation