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 Board Member
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...
Joint Discussion Paper – Future Governance of Medical Technologies in the EU Six leading European industry organisations, including MedTech Europe, EFPIA, and EIT Health, have jointly published a vision paper on the future gove...
Remote, but Intense at Health Days 2025 On March 13–14, we took part in the international Health Days 2025 conference held in Vienna. This time, our meetings were conducted remotely — but th...
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 Board Member
