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...
by Waltteri Sorvisto | Feb 26, 2026 | Medical Device Services
For many medical device manufacturers, the Quality Management System evolves gradually. What begins as a practical documentation framework eventually becomes a structured system designed to withstand regulatory scrutiny, external audits, and organisational growth. At...
by Waltteri Sorvisto | Feb 19, 2026 | Medical Device Services
In recent months, we have had many discussions with manufacturers about electronic Quality Management Systems (eQMS). Interestingly, the conversations often start the same way. Companies feel they have simply outgrown their current setup. What once worked well,...
by Waltteri Sorvisto | Feb 12, 2026 | CRO
Before a clinical investigation begins, one of the most important questions must be clearly answered: What exactly is the manufacturer trying to prove? Clinical investigations do not exist in isolation. They must be directly aligned with the device’s intended use, its...
by Waltteri Sorvisto | Feb 5, 2026 | Medical Device Services
In recent months, we have seen a growing number of non-EU medical device manufacturers reaching out with questions about the European Authorized Representative (EC REP) role. In many cases, the trigger is straightforward: access to the EU market requires an EC REP....
