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    Medtech Compliance Forum │ Part of Labquality Days

    Scientific programme

    The scientific programme for the Medtech Compliance Forum features three dedicated tracks in healthtech development, clinical & performance evidence, and IVDs.

    Register your spot

    Day 1: Thursday, 11 Feb 2027

    8:00-9:00  Registration, coffee & exhibition

    9:00-9:15   Opening words for Labquality Days

     Track 1: Developing Health Technology 

    10:15-10:20 Introduction

    10:20-11:00

    Digital Health Under MDR: Software, AI, and the Expanding Boundary of Medical Devices

    TBD 

    11:00-11:40

    Governance and Post-Market Monitoring of Healthcare AI

    Catarina Carrao, BioSciPons 
    11:40-13:10 Lunch & exhibition 

    13:10-13:55

    Slippery slope and methods to ride it: An AI drift

    TBD 

    13:55-14:30

    Key components of good clinical evidence for AI device

    Ilkka Juuso, SGS 
    14:30-15:00 Coffee & exhibition 

    15:00-16:00

    RW Testing of AI

    Erik Vollebregt, Axon Lawyers

    Koen Cobbaert, Philips 

    16:00-17:00 Exhibition 
     Track 2: Clinical and Performance Evidence
    10:15-10:20 Introduction 

    10:20-11:00

    ISO 18969 Explained: Practical Clinical Evidence Expectations

    Danielle Giroud, MD-Clinicals

    11:00-11:35

    Real-World and Digital Evidence Under MDR & IVDR: From Theory to Acceptance

    TBD

    11:35-12:10

    Simulated Clinical Evidence: Regulatory Acceptance and Future Applications

    TBD 
    12:10-13:40 Lunch & exhibition 

    13:40-14:15

    Why CERs Still Fail: Lessons from NB Assessments

    TBD 

    14:15-14:50

    Post-Market Evidence Generation for Software and AI Medical Devices: Designing Effective PMCF and PMPF Strategies

    Mihir Kelshiker, Scarlet

    14:50-15:20 Coffee & exhibition  

    15:20-16:00

    CECP Requirements Meets Clinical Reality

    Reeta Levo, Bioretec 

    16:00-17:00 Exhibition 

     

     

    Day 2: Friday, 12 Feb 2027

    8:00-9:00  Registration, coffee & exhibition

     Track 1: Developing Health Technology 

    9:00-9:05 Introduction

    9:05-9:40

    The network of must-have's and can't do's - The relationship of MDR, IVDR, AI and standard

    Ilkka Juuso, SGS

    Marika Karjalainen, Aurevia  

    9:40-10:15

    MDSW and Rule 11 - 101 ways to interpret a rule

    Erik Vollebregt, Axon Lawyers 

    10:15-10:50

    Ambient Scribes in Healthcare, any regulatory questions?

    Reetta Hintsanen, GostaLabs 
    10:50-12:15 Lunch & exhibition 

    12:15-12:50

    Translating EHDS Requirements into Concrete Software Design

    TBD 

    12:50-13:25

    SBOM as a Window into MDSW Design: Why It’s All in the Script

    Krishnadev Moothandassery Ramdevan, Aurevia  

    13:25-14:00

    Vibe coding and AI tools in RW

    Jari Martelin, Finnish Red Cross 

    14:00-14:15 Coffee & exhibition 

     14:15-15:00 Labquality Days plenary lecture 
     Track 3: In Vitro Diagnostics (IVD)
    9:00-9:05 Introduction 

    9:05-9:45

    The Future of European Diagnostics and Biotech: What the IVDR Revision and Biotech Act Mean for Industry

    TBD 

    9:45-10:15

    In-House Tests under the IVDR: Competent Authority Expectations for Clinical Laboratories

    TBD 

    10:15-10:50

    "How to shepard your IVDs through the tail of legacy devices transition?"

    Molly Rogers, DNV 
    10:50-12:15 Lunch & exhibition 

    12:15-13:00

    What Notified Bodies Expect from IVDR Performance Evaluation of Software IVDs

    Mari Levula, SGS 

    13:00-13:40

    How to Keep Your IVDR CE Certificate: Insights from Follow-Up Audits and Real-World Challenges

    Rina Wahlroos, Aidian 

    13:40-14:15 Coffee & exhibition 

    14:15-15:00 Labquality Days plenary lecture 

     

     

    Secure your spot

    Register today and take advantage of early bird pricing.

    1-day pass
    Early bird rate: 530€ (excluding VAT)
    2-day pass
    Early bird rate: 570€ (excluding VAT)
    Part of Labquality Days

    Medtech Compliance Forum by Aurevia & RAPS

    The Medtech Compliance Forum by Aurevia & RAPS will host scientific program tracks in health technology development, clinical & performance evidence and IVDs, combining global regulatory expertise, market insights, and practical real-world experience.

    As part of Labquality Days, one of Northern Europe’s largest annual congresses in laboratory medicine and health technology, the forum benefits from an established, international platform. It provides valuable opportunities to learn, exchange experiences, and build connections that support innovation and compliance in medtech.

    As an attendee, you will have access to the programme tracks for Labquality Days and the Medtech Compliance Forum tracks.

    The Medtech Compliance Forum is designed for:

      • Quality & Regulatory professionals
      • Medical device & IVD professionals
      • Professionals working with clinical development and compliance
      • Product and development managers
      • Medtech leaders & decision-makers

    📍 Messukeskus Expo and Convention Centre, Helsinki, Finland
    📅 SAVE THE DATE: 11–12 February 2027
              1000+ Industry professionals
              40+ Countries represented
              50+ Companies represented
              50+ Years of Labquality Days
    LabQuality-46

    Hosted together in partnership by:

    RAPS logo v2
    aurevia-logo
    Labquality-Days-logo

    Why attend?

      • Learn from leading experts: Gain insights from respected voices in regulatory affairs, quality assurance, and clinical research across Europe and beyond.
      • Stay ahead in a changing regulatory landscape: Explore key topics such as MDR, IVDR, clinical evidence, and regulatory strategy.
      • Connect with the right audience: Meet professionals across healthcare, diagnostics, and the medical & health technology sectors.
      • Turn compliance into opportunity: Understand how regulatory strategy can support business growth and market access.

    Questions? Contact us
    Aurevia - Your partner in medtech compliance and clinical research

    Together, we build trust in tomorrow's healthcare

    With proven track records, our experts help you gain the insights you need to accelerate your product development. 
    Contact us