by Waltteri Sorvisto | Dec 18, 2025 | Medical Device Services
Recently, the European Commission published a proposal for changes to the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). This proposal reflects ongoing efforts to improve how these regulatory frameworks operate in...
by Waltteri Sorvisto | Dec 11, 2025 | Medical Device Services
This year’s Medica fair once again demonstrated why it remains one of the most influential events in the medical technology world. From visionary start-ups to seasoned industry leaders, the entire ecosystem was buzzing with new ideas, emerging technologies, and a...
by Waltteri Sorvisto | Nov 13, 2025 | Medical Device Services
Artificial Intelligence (AI) is transforming medical devices—from diagnostic algorithms to adaptive therapeutic systems. But bringing an AI-enabled medical device to market in the EU demands more than software development. You must align with the MDR (EU 2017/745),...
by Waltteri Sorvisto | Oct 30, 2025 | Medical Device Services
Bringing a medical device to the European market requires more than innovative technology — it demands meticulous documentation and clear evidence of safety and performance. Under the EU Medical Device Regulation (MDR 2017/745), your Technical File and Clinical...
by Waltteri Sorvisto | Sep 25, 2025 | Medical Device Services
In the world of medical devices under EU MDR (EU 2017/745), the clinical evaluation process is a cornerstone of demonstrating safety and performance. At its heart are two interlinked documents: the Clinical Evaluation Plan (CEP) – which defines how you’ll gather...
by Waltteri Sorvisto | Sep 18, 2025 | Medical Device Services
Biological safety remains a critical part of bringing a medical device to market under EU MDR (EU 2017/745). Two documents in particular matter: the Biological Evaluation Plan (BEP), which lays the groundwork for identifying and managing biological risks; and the...
