by Waltteri Sorvisto | Jan 22, 2026 | Medical Device Services
Over the past months, we have seen a growing number of manufacturers reaching out with questions about the Person Responsible for Regulatory Compliance (PRRC). In many cases, the initial question is straightforward: Who can act as our PRRC under MDR or IVDR? Very...
by Waltteri Sorvisto | Jan 15, 2026 | Medical Device Services
After the quieter holiday period, many organisations are now fully back at work. With that return often comes a familiar reality for medical device manufacturers: internal audits to plan and complete, and notified body audits on the horizon. This is a natural point in...
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...
