Join our Workshop on Building Clinical Evidence for MedTech!
Join us for a hands-on morning session designed to support MedTech startups and scale-ups as they take their first steps toward clinical investigation. Whether you’re preparing for your first-in-human study or planning your clinical strategy, this event will help you avoid common pitfalls and focus on what really matters to succeed. You’ll hear from experienced […]
Safety Data That Makes a Difference – Insights from Safety Manager Ida Björklund
In clinical studies, the responsibility for ensuring patient safety lies with both the sponsors and the clinical study staff. This is not only a regulatory requirement, outlined in standards such as the MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), but also a core principle of Good Clinical Practice (GCP) and its ISO […]