News
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
Medical devices regulation
EUDAMED: Upcoming Obligations for Medical Device Manufacturers
Medical devices regulation
EUDAMED v3.11.0 - What medical device manufacturers should know
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
MD, AI and Cybersecurity
Simplify Regulatory Compliance for AI-Powered Medical Devices with the Team NB and IG-NB Questionnaire
Medical devices regulation
MDCG 2023-3 Rev.1: New Vigilance Requirements for Medical Device and IVD Manufacturers
News
Practical Guide: Submitting Technical Documentation under MDR (EU) 2017/745
Medical devices regulation
Q&A on Amendment 2024/1860 to MDR/IVDR: New Transparency and Safety Obligations for Medical Device Manufacturers
Medical devices regulation
MDCG 2022-5 revision 1 Guide: Clarification and Requirements for the Compliance of Medical Devices and Medicinal Products in Europe
Medical devices regulation
MDCG Guide 2024-13: What Medical Device Manufacturers Need to Know About Ethylene Oxide Sterilization
News
Urgent Revision of MDR and IVDR in 2024: What Manufacturers Need to Know
Medical devices regulation
Revision of the MDCG 2021-25 Guide: What Medical Device Manufacturers need to know
Medical devices regulation