When Does a Medical Device Company Need CRO Support?
Clinical investigations rarely place the same demands on every medical device company. Some organisations have experienced internal clinical teams and need support only with a specific phase, such as monitoring or authority submissions. Others may need broader...
Summer at MDS: Keeping QA/RA Work Moving
As the summer holiday season begins to draw to a close, teams across the medical device industry are gradually returning to their usual routines. At MDS, the summer months have remained active. While project schedules may look different during the holiday period,...
FDA QMSR and ISO 13485: What European Medical Device Companies Should Understand
For European medical device companies, entering the US market often requires adjusting to a different regulatory system. The FDA pathway has its own terminology, submission routes, inspection expectations, and post-market requirements. Even companies with mature EU...
How External QA/RA Support Strengthens Regulatory Readiness
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...
MDR Internal Audits: A Practical Check on Compliance and Continuous Readiness
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...
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 functional,...
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...