Janne West
Senior Quality & Regulatory Affairs Consultant
Aurevia
Sweden
Janne West, PhD, is a Senior Quality and Regulatory Consultant with extensive experience in medtech, software as a medical device, and regulated product development. With a background spanning medical sciences, computer engineering and regulatory affairs, he helps medtech and SaMD companies bridge the gap between regulatory requirements and technical implementation.
Topics
Translating EHDS Requirements into Concrete Software Design
International Programme
Developing Health Technology
12.2.2027 12:15 - 12:50 | Branded Lecture Hall 1
The European Health Data Space (EHDS) introduces new requirements governing the use and exchange of electronic health data across Europe. This presentation examines how these requirements can be translated into practical and verifiable software requirements, with examples relating to interoperability, data access, logging, security and verification.
It will also consider the interplay between the EHDS, EU MDR, and AI Act. Particular attention will be given to the implications for software development and technical documentation. The aim is to provide a practical perspective on turning regulatory obligations into implementable software design decisions.