Blog

MHRA Guidance on New Medical Devices: Post-Market Surveillance Requirements

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidance on post-market surveillance (PMS) requirements for m...

Agnieszka Czajkowska Senior Regulatory and Clinical Affairs Consultant

A year of breakthroughs in medical devices and in vitro diagnostics: Summary of 2024 year

The year 2024 has been a time of intensive changes and challenges for the medical device and in vitro diagnostics (IVD) industries. As active particip...

Katarzyna Wesołowska Board Member
Konferencja B+R

B+R VIII Conference: Driving R&D Strategies in Polish Industry

Last week, Pure Clinical and MDR Regulator had the privilege of attending the B+R VIII Conference, an event dedicated to advancing the effective imple...

Adam Sobantka at MEDmeetsTECH 18

On December 5, 2024, Adam Sobantka, the CEO of Pure Clinical, delivered a presentation at the 18th edition of the MEDmeetsTECH conference in Warsaw. D...

Pure Clinical and MDR Regulator at Warsaw Medical Expo

The 2nd edition of the Warsaw Medical Expo, held on November 26–28, 2024, has come to a successful close. It was an exceptional event that brought tog...

Katarzyna Wesołowska Board Member

MDR Regulator at Warsaw Medical Expo

The Warsaw Medical Expo has come to an end, marking another successful event for MDR Regulator. Our presence at the trade fair provided an opportunity...

Katarzyna Wesołowska Board Member

Artificial Intelligence in Medical Devices Questionnaire published by TEAM-NB

The Artificial Intelligence in Medical Devices Questionnaire, developed by Team-NB and IG-NB, is an essential guideline designed to align AI-based med...

Katarzyna Wesołowska Board Member

Expert Panels Support for Orphan Medical Devices: EMA’s Pilot Programme

On 20 November 2024, the Expert Panels published templates to assist manufacturers and notified bodies in applying for advice under the EMA's pilot pr...

Pure Clinical and MDR Regulator at MEDICA 2024

We have just wrapped up an amazing few days at MEDICA 2024, the premier global medical technology trade fair. This year, our focus was on expanding ou...