by Waltteri Sorvisto | May 7, 2026 | Medical Device Services
Medical device development often begins with a strong technical idea. For startups, that early momentum is important. A prototype, a clinical need, or a promising technology can create the energy needed to move a product forward. But in medical device development,...
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 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...
by Waltteri Sorvisto | Mar 12, 2026 | Medical Device Services
For many medical device manufacturers, the role of the Quality Manager is central to maintaining compliance, supporting regulatory strategy, and ensuring that quality processes function effectively across the organisation. However, building and maintaining the right...
