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 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....
by Waltteri Sorvisto | Jan 22, 2026 | Medical Device Services
Over the past months, we have seen a growing number of manufacturers reaching out with questions about the Person Responsible for Regulatory Compliance (PRRC). In many cases, the initial question is straightforward: Who can act as our PRRC under MDR or IVDR? Very...
by Waltteri Sorvisto | Jan 15, 2026 | Medical Device Services
After the quieter holiday period, many organisations are now fully back at work. With that return often comes a familiar reality for medical device manufacturers: internal audits to plan and complete, and notified body audits on the horizon. This is a natural point in...
