Medical devices regulation
News about medical devices
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
MDCG 2024-12: What It Means for Manufacturers in the Medical Device Industry
Medical devices regulation
New MDCG 2024-11 Guidance
Medical devices regulation
Complete Guide to MDR Codes: How to Use MDA, MDN, MDS, and MDT Codes for Medical Device Compliance
Medical devices regulation
MDR Documentation: Avoid Common Mistakes and Follow Best Practices
Medical devices regulation
Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices
MD, AI and Cybersecurity
The AI risk repository
News
Sun Tzu and Medical Devices
News
CSDmed Supports Keenamics in Innovating Ankle Rehabilitation
Medical devices regulation
New Regulation (UE) 2024/1860
Medical devices regulation
New guide MDCG 2021-5 rev1 - Guidance on standardisation for medical devices
Medical devices regulation
Harmonized structure for IVD regulatory submissions
Medical devices regulation
MDCG 2024-10 Clinical evaluation of orphan medical devices
Medical devices regulation
Comprehensive Update on the Guidelines for Benefit-Risk Assessment of CMR/ED Phthalates in Medical Devices
Medical devices regulation
Methods Validation for Verification Testing in Medical Devices
News
Insight into the Medical Devices Sector in 2023: Key Data and Trends
Medical devices regulation
Supercritical CO₂ Sterilization: An Eco-Friendly and Sustainable Alternative for Medical Devices
Medical devices regulation
Post Market Surveillance
Medical devices regulation
MDCG 2024-5 - guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
MD, AI and Cybersecurity
Successful and timely uptake of artificial intelligence in science in the EU
MD, AI and Cybersecurity
Statement of Applicability according to section 6.1.3 of ISO/IEC 42001:2023
MD, AI and Cybersecurity
How far can data support the transformation of health through AI?
News
Competent authorities and medical devices registration
News
Harmonized standards up to date in March 2024
Medical devices regulation
MDCG 2024-3 guidance - content of the Clinical Investigation Plan (CIP)
MD, AI and Cybersecurity
NIS 2 Directive
MD, AI and Cybersecurity
HLS structure within ISO-IEC 42001
News
ISO and IAF Joint Communiqué about Climate Change
Medical devices regulation
EU Guide: EUDAMED overview and how to register your company
Medical devices regulation
MDCG 2024-2 about update of EMDN codes
News
IA act: France finally accepts the proposal, under conditions
Medical devices regulation
language requirements for manufacturers
News
NANDO base - situation on the 1st January 2024
Medical devices regulation
MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access to data needed to justify claims of equivalence
MD, AI and Cybersecurity
ISO 42001:2023 Artificial intelligence - Management system
Medical devices regulation
MDCG 2021-27 Rev.1 - roles and responsibilities of importers and distributors of medical devices
Medical devices regulation
MDCG 2019-07 Rev.1 (PRRC)
Medical devices regulation
MDCG 2023-5 and MDCG 2023-6: two for the price of one - Products without an Intended Medical Purpose under Annex XVI
Medical devices regulation
New release: MDCG 2021-6 Rev. 1 - Questions & Answers regarding clinical investigation
News
(EC) 2023/2482 amending Regulation (EC) No 1907/2006
Medical devices regulation
New issue of the MDCG Position Paper : MDCG 2022-11 revision 1 - Notice to manufacturers and NB
Medical devices regulation
Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
Medical devices regulation
Implementing Regulation (EU) 2022/2346 and (EU) 2023/1194 of the arrangements in Annex XVI of MDR 2017/745 - risk management and transitional provisions
Medical devices regulation
The calendar according to amending regulation 2023/607
Medical devices regulation
Guidance on machine learning-enabled medical devices (MLMD)
Medical devices regulation
New amending document for EU MDR 2017/745: the EU 2023/2197
Medical devices regulation
New MDCG 2023-4 guidance: Medical Device Software (MDSW) - Hardware combinations
Medical devices regulation
Medical devices classification
Medical devices regulation
New manual on borderline and classification for medical devices
Medical devices regulation
What is a medical device ?
Medical devices regulation
New issue of the FDA Guidance : Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
Medical devices regulation
Understanding the Imperative of Risk Management Plan (RMP) in Medical Devices
Medical devices regulation
The hidden risks of sourcing medical equipment from China
News
Exciting News! CSDmed is Now a Member of the AFNOR Adherents Club
News
Come, find and meet us during the 11th edition of "la rentrée du DM" at the Kursaal of Besançon.
Medical devices regulation
MDR 2017/745 consolidated with regulations 2023-607 and 2020-561
Medical devices regulation
MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Medical devices regulation
Extension of transitional period of Medical Device Regulation (MDR 2017/745)
Medical devices regulation
MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR
Medical devices regulation
MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation - December 2021
Medical devices regulation