by Waltteri Sorvisto | Oct 8, 2026 | Medical Device Services
When companies look for external quality or regulatory support, the immediate need is often easy to describe. A quality management system needs to be implemented, technical documentation needs to be completed, an audit is approaching, or a particular regulatory...
by Waltteri Sorvisto | Oct 1, 2026 | Medical Device Services
Medical device projects can go surprisingly far before one of the most fundamental questions has been answered properly: What exactly is the device intended to do, for whom, and under which conditions? For an early-stage company, an unclear intended purpose can send...
by Waltteri Sorvisto | Sep 24, 2026 | CRO, Medical Device Services
A clinical investigation can be well managed, completed according to plan and still leave the manufacturer with an uncomfortable question: Did we actually generate the evidence we need? For medical device companies, the purpose of a clinical investigation is not...
by Waltteri Sorvisto | Sep 17, 2026 | Medical Device Services
When biological safety comes up in a medical device project, the first question is often: Which biocompatibility tests do we need? That is understandable, but it is usually not the best place to start. Biological evaluation is not simply a list of laboratory tests. It...
by Waltteri Sorvisto | Sep 10, 2026 | Medical Device Services, Product & Compliance
When developing medical device software, the natural temptation is to focus first on the product. Build the algorithm. Develop the application. Connect the data. Test whether the concept works. For regulated medical software, however, development cannot be separated...
by Waltteri Sorvisto | Sep 3, 2026 | FDA, Medical Device Services, Technical Documentation
A medical device company planning to enter both the European and US markets does not necessarily need to treat the two regulatory pathways as completely separate projects. The submissions themselves are different, and the regulatory logic behind them is different. But...
