AI & MedTech CEE 2025: shaping the future of healthcare AI On June 10, we had the opportunity to attend the AI & MedTech CEE conference – a meeting of innovators, regulators, and visionaries shaping the future...
Health Business Innovation 2025 – shaping the future of MedTech in Katowice On June 5, we participated in Health Business Innovation 2025 in Katowice – an inspiring event full of practical insights and forward-thinking discuss...
Pure Clinical at the 11th “Clinical Trials Are for You” Conference On the occasion of International Clinical Trials Day, the Pure Clinical team participated in the 11th edition of the “Clinical Trials Are for You” con...
LifeScience4EU Conference 2025 – wrapped up! Two intensive yet remarkably fruitful days of engaging discussions, expert panels, and meaningful networking marked the LifeScience4EU Conference 2025...
Switzerland implements simplified market access pathway for high-risk medical devices Switzerland has adopted regulatory changes enabling temporary authorization for high-risk medical devices even without MDR or Swiss approval. The law... Katarzyna Wesołowska Vice President of the Board
Team-NB Updates Best Practice Guidance on MDR Technical Documentation The updated Team-NB guidance on technical documentation provides manufacturers with a comprehensive framework to build MDR-compliant technical files... Katarzyna Romaniszyn Head of Regulatory and Quality Management Department
Shaping the future of MedTech professionals – postgraduate program at Bialystok University of Technology Another inspiring weekend behind us! Our experts from Pure Clinical and MDR Regulator once again led engaging sessions as part of the postgraduate pro... Agnieszka Czajkowska
Clinical Investigations of Medical Devices in the UK – Updated MHRA Requirements In the United Kingdom, any clinical investigation involving a non-UKCA/CE-marked device that is not yet commercially available must be submitted for a... Ilona Korczak-Cegielska Director of Clinical and Regulatory Operations
Our Delegation at LABS EXPO 2025 in Poznań LABS EXPO 2025 in Poznań (March 19–20) was one of the most important events for the diagnostics and laboratory technology sector in Central Europe. Na...
