PRRCs and QA/RA teams carry a wide set of responsibilities. Technical documentation, clinical evidence, post-market surveillance, vigilance, supplier control, quality systems, audit readiness, regulatory strategy, and authority communication all need attention. In...
Internal audits are sometimes treated as a routine requirement. Something that needs to be scheduled, completed, documented, and closed before the next external audit or certification milestone. In practice, they can be much more valuable than that. A well-conducted...
In the first part of this series, we looked at the early decisions that shape a medical device project: intended use, requirements, risk management, regulatory strategy, and clear responsibilities. Once the direction is set, the next challenge is building the...
Medical device development often begins with a strong technical idea. For startups, that early momentum is important. A prototype, a clinical need, or a promising technology can create the energy needed to move a product forward. But in medical device development,...
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 functional,...
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: catheter-based...
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. When...
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 right...
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...
