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...
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...
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:...
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....
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...
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...
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....
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,...
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....
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...
