The Medical Device Startup Playbook: Build the System as You Develop
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...
The Medical Device Startup Playbook: Set the Direction Early
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,...
EUDAMED deadlines are approaching. What medical device companies should do now
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...
Understanding the Cyber Resilience Act: From Requirements to Practical Implementation
The Cyber Resilience Act (CRA) introduces a new layer of requirements for products with digital elements, with the goal of improving cybersecurity across the EU market. For many companies, the structure of CRA will feel familiar. It places responsibility on...
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....