Blog

MDR Regulator at MedTech Summit in Budapest!

Last week, for the second consecutive year, we participated in the MedTech Summit in Budapest – one of the key industry events dedicated to medical de...

Katarzyna Wesołowska Vice President of the Board

IMDRF Terminologies for Categorized Adverse Event Reporting (AER)

The International Medical Device Regulators Forum (IMDRF) has published standardized terminologies for reporting adverse events related to medical dev...

Enhancing Accessibility in Rapid Diagnostic Tests: WHO’s New Guidance

Access to accurate and easy-to-use diagnostic tests is essential for public health, but many testing tools are not designed with all users in mind. In...

MFDS of South Korea and HSA of Singapore

The Ministry of Food and Drug Safety (MFDS) of Korea and the Health Sciences Authority (HSA) of Singapore have jointly released guiding principles for...

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

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 Vice President of the Board
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 Vice President of the Board