News about 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

Post Market Surveillance

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 2023-4 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

MDCG 2021-24 Guidance on classification of medical devices - October 2021