Medtech Compliance Forum: Explore This Year's Programme Tracks

The Medtech Compliance Forum by Aurevia & RAPS scientific programme features three dedicated tracks:
•    Developing Health Technology
•    Clinical & Performance Evidence
•    In Vitro Diagnostics (IVD)

According to Mika Siitonen, Head of the Medtech Compliance Forum, the scientific committee selected these tracks because they reflect three areas that continue to generate questions, challenges and opportunities across the medtech industry: developing health technologies, generating and maintaining clinical and performance evidence, and dealing with changing regulatory requirements for medical devices and IVDs. The IVD track also creates a natural connection with the laboratory community and the broader Labquality Days ecosystem.

DEVELOPING HEALTH TECHNOLOGY
This year, the track has a particular focus on digital health. However, the topics are highly relevant beyond purely digital products. In practice, digital health solutions rarely exist in isolation. They are often part of broader medical device ecosystems that combine software, hardware, connectivity and clinical workflows. The programme focuses on topics that many health technology companies are currently working with, including healthcare AI governance, clinical evidence, real-world testing, Rule 11, ambient scribes, software bills of materials, and the intersection of MDR, IVDR, AI and standards.

CLINICAL & PERFORMANCE EVIDENCE
This track focuses on how clinical and performance evidence can be generated and maintained from development to post-market activities. The track looks at how regulatory expectations translate into everyday decisions and activities, covering topics such as clinical evidence planning, real-world and post-market evidence generation, and the relationship between regulatory requirements and clinical reality.

IN VITRO DIAGNOSTICS
The IVD track focuses on the practical challenges currently faced by diagnostic manufacturers and clinical laboratories under IVDR. Topics include the legacy device transition, performance evaluation expectations for software IVDs, and practical experience from IVDR certification maintenance and follow-up audits.

All three tracks are designed to provide a balanced combination of practical experience and future perspectives. Together, the three tracks provide a broad view of the topics currently discussed across the medtech industry. Some sessions focus on long-term developments, while others are firmly grounded in everyday regulatory, quality and clinical work. Our ambition has been to ensure that there is something genuinely useful for everyone attending.

Explore the full programme 

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What is the Medtech Compliance Forum by Aurevia & RAPS?
The Medtech Compliance Forum by Aurevia & RAPS is a dedicated part of Labquality Days for professionals across the medtech field. The forum focuses on compliance, regulatory strategy, evidence requirements, and practical challenges throughout the product lifecycle in a rapidly evolving field. We warmly welcome medtech and healthtech professionals, medical device manufacturers, regulatory experts, quality leaders, and innovators to join us in 2027 and help shape the future of health technology.