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...
by Waltteri Sorvisto | Mar 5, 2026 | FDA, Medical Device Services
For many European medical device and IVD manufacturers, regulatory interaction often happens at defined checkpoints. Under the EU MDR or IVDR, communication with notified bodies typically becomes most intensive once documentation is ready for review and conformity...
