Medical devices regulation
Medical devices regulation
Biocompatibility and start-ups: how not to get lost in BEP, BER and TRA?
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)
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
Medical devices regulation
EUDAMED: Upcoming Obligations for Medical Device Manufacturers
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
EUDAMED v3.11.0 - What medical device manufacturers should know
Medical devices regulation
MDR harmonized standards: April 8, 2025 update, what manufacturers need to remember
Medical devices regulation
ISO 14971, ISO/TR 24971, IEC 60812 and IEC 61025: how to choose the right risk analysis methods for medical devices
Medical devices regulation
🇪🇺 EMDN Update 2025: What Medical Device Manufacturers Need to Know
Medical devices regulation
MDCG 2023-3 Rev.2: What Changes in Vigilance for MDs and IVDs in 2025?
Medical devices regulation
Publication of Clinical Investigation Reports: The MDCG 2024-15 Guide Explained
Medical devices regulation
MDCG 2024-14: Making Sense of Master UDI-DI for Contact Lenses
Medical devices regulation
MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers
Medical devices regulation
Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers
Medical devices regulation