From Clinical Investigation to CER: Making Sure the Evidence Is Actually Usable
A clinical investigation can be well managed, completed according to plan and still leave the manufacturer with an uncomfortable question: Did we actually generate the evidence we need? For medical device companies, the purpose of a clinical investigation is not...
Biological Evaluation Is More Than Biocompatibility Testing
When biological safety comes up in a medical device project, the first question is often: Which biocompatibility tests do we need? That is understandable, but it is usually not the best place to start. Biological evaluation is not simply a list of laboratory tests. It...
Developing Medical Device Software: Build the Product and the Evidence Together
When developing medical device software, the natural temptation is to focus first on the product. Build the algorithm. Develop the application. Connect the data. Test whether the concept works. For regulated medical software, however, development cannot be separated...
Planning Your MDR and FDA Pathways Together
A medical device company planning to enter both the European and US markets does not necessarily need to treat the two regulatory pathways as completely separate projects. The submissions themselves are different, and the regulatory logic behind them is different. But...
How External QA/RA Expertise Can Strengthen Your Internal Team
Strong quality and regulatory teams are fundamental to medical device companies. They understand the product, the organisation, its history, and the practical realities behind the quality management system. They are often the people connecting product development,...
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...