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 | Oct 2, 2025 | Commerzialisation
Germany is one of Europe’s largest healthcare markets, but successfully bringing a medical device to German patients requires more than MDR certification. To be competitive, manufacturers must also consider reimbursement pathways early in their market strategy....
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...
by Waltteri Sorvisto | Sep 11, 2025 | FDA, Medical Device Services
For many medical device companies, the United States is not only one of the largest healthcare markets in the world—it’s also a gateway to global opportunities. FDA clearance or approval is widely recognized as a gold standard in medical device regulation, and...
