When a medical device moves from concept to market, the real differentiator isn’t the technology itself, it’s how rigorously the development process is orchestrated. A well‑defined set of requirements, anchored in regulatory reality and backed by cross‑functional collaboration, is the only way to keep projects on schedule, stay within budget, and avoid costly compliance surprises.

In this guide we break down a pragmatic, three‑phase framework for structuring requirement definition and project management. We’ll show why involving regulatory, clinical, design, and quality experts from day one is non‑negotiable, how early integration of MDR/FDA demands saves time and money, and which strategic moves, such as picking the right Notified Body or launching with a focused scope, keep the development pipeline flowing smoothly. 

If you’re a QA/RA professional looking for a no‑fluff roadmap that actually works in the field, the steps below will give you the concrete actions you need to turn ideas into compliant, market‑ready devices.

Under the EU Medical Device Regulation (MDR), manufacturers are required to demonstrate that their products are clinically safe and effective. This requires robust clinical data, particularly for higher-risk devices. Clinical investigations sit at the intersection of scientific discovery and regulatory compliance. 

We spoke with one of Dawn Technology’s regulatory consultants, Erwin Waas, about the complexities of clinical investigations, how clinical data requirements are managed, and the vital role he and his colleagues play in guiding medtech companies and scientists through the compliance process.

AI is reshaping the compliance burden for medical device companies in the EU. Thankfully, for makers of medical devices containing AI, the Medical Device Coordination Group (MDCG) has released a crucial piece of guidance material.

MDCG 2025-6 outlines the interplay between the EU’s Medical Device Regulation (MDR), In Vitro Diagnostic Medical Device Regulation (IVDR), and the Artificial Intelligence Act (AI Act). It comes just in time: the full application of the AI Act to high-risk systems, including medical devices, is set to take effect one year from now.  

We sat down with Dawn Technology (formerly Peercode) regulatory consultant Marijn Maas to unpack the implications of this landmark guidance and what vendors of medical device software can do to prepare.