Leon Doorn

• Leon Doorn

Technical File Remediation: Closing 60+ Notified Body Queries in Four Weeks

• Leon Doorn

Advancements in AI/ML Standards

Summary Artificial intelligence is evolving faster than the regulatory frameworks around it. But that gap is beginning to close, with

• Leon Doorn

You Can’t Escape CE Marking

Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the

• Leon Doorn

Role of the Authorised Representative

Summary An EU Authorised Representative plays a critical role for medical device and in vitro diagnostic manufacturers established outside the

• Leon Doorn

MDR & IVDR Regulatory Post-Market Complexities

Summary The MDR and IVDR have significantly changed the regulatory landscape for medical devices in Europe, extending responsibilities and liabilities

• Leon Doorn

Large Language Models (LLMs) in Healthcare: A European Perspective

Summary Large Language Models (LLMs) are rapidly reshaping healthcare, supporting everything from administrative efficiency to clinical workflows. While their adoption

• Leon Doorn

Implications of the EHDS regulation for SaMDs and AI/ML-enabled Medical Devices

Summary The European Health Data Space (EHDS) Regulation represents a significant step towards creating a more connected and interoperable healthcare

• Leon Doorn

The EU Commission’s proposed implications on SaMD and AI-enabled devices

Summary The EU Commission SaMD proposal introduces significant changes that could reshape the regulatory landscape for Software as a Medical

• Leon Doorn

Third-Party LLMs in Medical Devices – QMS implications

Summary Medical Device QMS requirements are evolving as third-party large language models (LLMs) become part of AI-enabled medical devices. While