by Waltteri Sorvisto | Apr 16, 2026 | Medical Device Services
For medical device and IVD manufacturers in Europe, EUDAMED is moving from something to prepare for into something that must be actively managed. The timeline is now clear. Following the European Commission’s notice that the first four EUDAMED modules are functional,...
by Waltteri Sorvisto | Apr 9, 2026 | Commerzialisation
The Cyber Resilience Act (CRA) introduces a new layer of requirements for products with digital elements, with the goal of improving cybersecurity across the EU market. For many companies, the structure of CRA will feel familiar. It places responsibility on...
by Waltteri Sorvisto | Apr 2, 2026 | Medical Device Services
This is the second part of our series on catheter-based development, following the journey from early design through preclinical evaluation. If you missed the first part, you can read it here! With a functional and tested system in place, the focus shifts toward...
by Waltteri Sorvisto | Mar 26, 2026 | Medical Device Services
Last year, we shared a three-part series on the development of a heart implant, following the journey from early design through clinical evaluation and regulatory preparation. In this series, we turn our attention to another critical part of that work: catheter-based...
by Waltteri Sorvisto | Mar 19, 2026 | Medical Device Services
Bringing a medical device to market has never been simple, but over the past decade, it has become significantly more complex. What was once a more linear process has evolved into a highly interconnected system of regulatory, clinical, and technical requirements. When...
