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 Board Member
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
