by Waltteri Sorvisto | Jun 11, 2026 | FDA, Quality Management
For European medical device companies, entering the US market often requires adjusting to a different regulatory system. The FDA pathway has its own terminology, submission routes, inspection expectations, and post-market requirements. Even companies with mature EU...
by Waltteri Sorvisto | May 28, 2026 | Medical Device Services
PRRCs and QA/RA teams carry a wide set of responsibilities. Technical documentation, clinical evidence, post-market surveillance, vigilance, supplier control, quality systems, audit readiness, regulatory strategy, and authority communication all need attention. In...
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,...
