News about medical devices

News

MDR: what does the transfer agreement published by Team-NB really change?

14-11-2025

News

Pilot coordinated assessment for CI/PS: a new step towards European coordinated assessment of clinical studies

10-11-2025

News

MedTech start-ups: how to get a CE marking project off to a good start?

04-11-2025

News

ISO 13485 for start-ups: 3 realistic approaches

03-10-2025

News

FDA vs MDR: 5 differences that matter to DM manufacturers

12-07-2025

News

IVDR and IVD Software: How to Properly Qualify and Classify Your Software

27-06-2025

News

CECP Procedure: What Should Medical Device Manufacturers Watch Out For?

24-06-2025

News

MDR CE marking: pitfalls to avoid as a start-up

07-06-2025

News

ISO 14971 and start-ups: how to get started on risk analysis without getting lost

14-05-2025

News

MDR technical file submission: what manufacturers really need to take care of (Team-NB, April 2025)

09-04-2025

News

MD or not MD? What the ANSM guide to borderline cases really says (April 2025)

04-04-2025

News

Medicinal products used with a medical device: what does the EMA guideline on quality documentation have to say?

27-03-2025

News

What is good regulatory support for a start-up?

29-12-2024

News

MedTech start-ups: where to begin preparing for CE marking?

16-12-2024

News

Practical Guide: Submitting Technical Documentation under MDR (EU) 2017/745

06-11-2024

News

Urgent Revision of MDR and IVDR in 2024: What Manufacturers Need to Know

24-10-2024

News

Sun Tzu and Medical Devices

07-08-2024

News

CSDmed Supports Keenamics in Innovating Ankle Rehabilitation

24-07-2024

News

Insight into the Medical Devices Sector in 2023: Key Data and Trends

16-05-2024

News

Competent authorities and medical devices registration

27-03-2024