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- MDCG 2024-12: What It Means for Manufacturers in the Medical Device Industry
- New MDCG 2024-11 Guidance
- MDR Documentation: Avoid Common Mistakes and Follow Best Practices
- The AI risk repository
- Sun Tzu and Medical Devices
- CSDmed Supports Keenamics in Innovating Ankle Rehabilitation
- New Regulation (UE) 2024/1860
- New guide MDCG 2021-5 rev1 - Guidance on standardisation for medical devices
- Harmonized structure for IVD regulatory submissions
- MDCG 2024-10 Clinical evaluation of orphan medical devices
- Comprehensive Update on the Guidelines for Benefit-Risk Assessment of CMR/ED Phthalates in Medical Devices
- Methods Validation for Verification Testing in Medical Devices
- Insight into the Medical Devices Sector in 2023: Key Data and Trends
- Post Market Surveillance
- MDCG 2024-5 - guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
- Successful and timely uptake of artificial intelligence in science in the EU
- Statement of Applicability according to section 6.1.3 of ISO/IEC 42001:2023
- How far can data support the transformation of health through AI?
- Competent authorities and medical devices registration
- Harmonized standards up to date in March 2024
- MDCG 2024-3 guidance - content of the Clinical Investigation Plan (CIP)
- NIS 2 Directive
- HLS structure within ISO-IEC 42001
- ISO and IAF Joint Communiqué about Climate Change
- EU Guide: EUDAMED overview and how to register your company
- MDCG 2024-2 about update of EMDN codes
- IA act: France finally accepts the proposal, under conditions
- language requirements for manufacturers
- NANDO base - situation on the 1st January 2024
- 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
- ISO 42001:2023 Artificial intelligence - Management system
- MDCG 2021-27 Rev.1 - roles and responsibilities of importers and distributors of medical devices
- MDCG 2019-07 Rev.1 (PRRC)
- MDCG 2023-5 and MDCG 2023-6: two for the price of one - Products without an Intended Medical Purpose under Annex XVI
- New release: MDCG 2021-6 Rev. 1 - Questions & Answers regarding clinical investigation
- (EC) 2023/2482 amending Regulation (EC) No 1907/2006
- New issue of the MDCG Position Paper : MDCG 2022-11 revision 1 - Notice to manufacturers and NB
- Interface between the Regulations on clinical trials of medicinal products, medical devices and in vitro diagnostics
- Implementing Regulation (EU) 2022/2346 and (EU) 2023/1194 of the arrangements in Annex XVI of MDR 2017/745 - risk management and transitional provisions
- The calendar according to amending regulation 2023/607
- Guidance on machine learning-enabled medical devices (MLMD)
- New amending document for EU MDR 2017/745: the EU 2023/2197
- New MDCG 2023-4 guidance: Medical Device Software (MDSW) - Hardware combinations
- Medical devices classification
- New manual on borderline and classification for medical devices
- What is a medical device ?
- 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"
- Understanding the Imperative of Risk Management Plan (RMP) in Medical Devices
- The hidden risks of sourcing medical equipment from China
- Exciting News! CSDmed is Now a Member of the AFNOR Adherents Club
- Come, find and meet us during the 11th edition of "la rentrée du DM" at the Kursaal of Besançon.
- MDR 2017/745 consolidated with regulations 2023-607 and 2020-561
- MDCG 2023-1 - Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
- Extension of transitional period of Medical Device Regulation (MDR 2017/745)
- MDCG 2022-16 Guidance on Authorised Representatives under MDR and IVDR
- MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation - December 2021
- MDCG 2021-24 Guidance on classification of medical devices - October 2021
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