Inside Our Catheter Development Project: From Validation to Clinical and Regulatory Readiness
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...
Inside Our Catheter Development Project: From Design Decisions to Preclinical Validation
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:...
10 Years of MDS: A Founder’s Perspective on a Decade of Change
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....
External Quality Manager: Scalable Expertise for Medical Device Companies
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...
Using FDA Q-Submissions Strategically: A Valuable Tool for Medical Device and IVD Companies
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...
Internal audits: Strengthening your QMS beyond compliance
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....
When Is It Time to Move to an eQMS? A Practical Perspective for Growing Medical Device Companies
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,...
Clinical Trial Management in Practice: Why Strong Project Oversight and Monitoring Matter
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,...
The European Authorized Representative Role in Practice: More Than a Legal Requirement
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....
The PRRC Role in Practice: More Than a Formal Appointment
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...
