by Waltteri Sorvisto | May 21, 2026 | Medical Device Services, Quality Management
Internal audits are sometimes treated as a routine requirement. Something that needs to be scheduled, completed, documented, and closed before the next external audit or certification milestone. In practice, they can be much more valuable than that. A well-conducted...
by Waltteri Sorvisto | May 13, 2026 | Medical Device Services
In the first part of this series, we looked at the early decisions that shape a medical device project: intended use, requirements, risk management, regulatory strategy, and clear responsibilities. Once the direction is set, the next challenge is building the...
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...
