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MedTechConf Event

Medtech Compliance Forum by Aurevia & RAPS 2027

Name: Medtech Compliance Forum by Aurevia & RAPS 2027
Start: 2027-02-11T06:00:00+00:00
End: 2027-02-12T13:00:00+00:00
Location: Helsinki, Finland

businessHosted by Aurevia & Regulatory Affairs Professionals Society (RAPS)

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Medtech Compliance Forum by Aurevia & RAPS 2027

About This Event

The Medtech Compliance Forum by Aurevia & RAPS takes place as part of Labquality Days 2027 in Helsinki, Finland. The conference brings together medical device and IVD manufacturers, regulatory affairs specialists, quality professionals, notified body experts and healthcare technology developers. The program explores EU MDR and IVDR, medical device software classification, AI governance, clinical evidence, clinical investigations, post-market monitoring, PMCF and PMPF, the European Health Data Space, cybersecurity documentation and regulatory market access.

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Date

Thursday, Feb 11, 2027–Friday, Feb 12, 2027

schedule

Time

08:00 AM

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Venue

Helsinki

Finland

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Hosted By

Aurevia & Regulatory Affairs Professionals Society (RAPS)

Speakers

CC
Catarina Carrão
Regulatory Clinical Evaluation & Assessment, BioSciPons, Austria
DG
Danielle Giroud
Chief Executive Officer, MD-CLINICALS, Switzerland
EV
Erik Vollebregt

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Helsinki, Finland | Messukeskus, 1, Messuaukio, Itä-Pasila, Pasila, Central major district, Helsinki, Helsinki sub-region, Uusimaa, Mainland Finland, 00520, Finland

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Medtech Compliance Forum by Aurevia & RAPS 2027

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Attorney-at-law/Partner, Axon Lawyers, The Netherlands

Ilkka Juuso

Lead Auditor, C&T Manager, SGS Fimko (NB 0598), Finland

Janne West

Senior Quality & Regulatory Affairs Consultant, Aurevia, Sweden

Jari Martelin

Clinical Director, Bittium Medical, Finland

Koen Cobbaert

Regulatory Science & Policy Expert, Philips, Belgium

Krishnadev Moothandassery Ramdevan

Senior Quality and Regulatory Consultant, Aurevia, Sweden

Lassi Rieppo

FIMEA

Marika Karjalainen

Quality & Regulatory Affairs Expert, Aurevia, Finland

Mihir Kelshiker

Clinical Scientist, Scarlet, UK

Molly Rogers

Head of IVDR, Medical Europe, DNV, Ireland

Nelli Karhu

Healthtech Finland

Reeta Levo

Bioretec

Reetta Hintsanen

Chief Operating Officer, Gosta Labs, Finland

Rina Wahlroos

VP, Quality and Regulatory Compliance, Aidian, Finland

Surash Surash

Senior Clinical Reviewer, TÜV SÜD, UK

Program

All times are in Europe/Helsinki.

Day 1Thursday, 11 February 2027

08:00 – 09:00
Registration, Coffee and Exhibition
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Registration and exhibition networking.
09:00 – 09:15
Opening Words
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Opening of the congress.
09:15 – 10:00
A Smarter Lab: How Automation, Clinical Decision Support & AI Shape Our Future
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The future of laboratory medicine through automation and AI.
10:20 – 11:00
Digital Health Under MDR: Software, AI, and the Expanding Boundary of Medical Devices
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MDR classification and regulatory requirements for digital health technologies.
- LRLassi Rieppo
10:20 – 11:00
What Makes or Breaks a Clinical Investigation?
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Clinical investigation planning and execution for medical devices.
- DGDanielle Giroud
11:00 – 11:40
Governance and Post-Market Monitoring of Healthcare AI
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Governance and ongoing monitoring of healthcare AI.
- CCCatarina Carrão
11:00 – 11:35
Real-World and Digital Evidence in Medical Device & IVD Regulation
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Regulatory applications of real-world and digital clinical evidence.
11:35 – 12:10
Simulated Clinical Evidence - In Silico Clinical Trials: Regulatory Acceptance and Future Applications
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Regulatory acceptance of simulated clinical evidence.
- SSSurash Surash
13:10 – 13:55
AI Drift and the Lifecycle Management of Medical AI
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Managing AI model changes and performance throughout the medical device lifecycle.
13:40 – 14:15
Why CERs Still Fail: Lessons from NB Assessments
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Common clinical evaluation report deficiencies identified by notified bodies.
13:55 – 14:30
Key Components of Good Clinical Evidence for AI Devices
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Clinical evidence expectations for AI-enabled medical devices.
- IJIlkka Juuso
14:15 – 14:50
Post-Market Evidence Generation for Software and AI Medical Devices: Designing Effective PMCF and PMPF Strategies
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Post-market clinical and performance evidence for medical device software and AI.
- MKMihir Kelshiker
15:00 – 16:00
Deploy First, Prove Later? The Rise of Real-World Testing in Healthcare
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Regulatory and clinical considerations for real-world testing of medical technologies.
- EVErik Vollebregt
- KCKoen Cobbaert
15:20 – 16:00
CECP Requirements Meets Clinical Reality
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Clinical evaluation consultation procedure requirements.
- RLReeta Levo

Day 2Friday, 12 February 2027

08:00 – 09:00
Registration, Coffee and Exhibition
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Morning registration and exhibition.
09:05 – 09:40
Mind the Gap – Navigating the Regulatory Metro Map
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Navigating medical technology regulatory pathways.
- IJIlkka Juuso
- MKMarika Karjalainen

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

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IVDR expectations for laboratory-developed in-house tests.

HVHanna Valo

09:40 – 10:15

MDSW and Rule 11 - 101 Ways to Interpret a Rule

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Classification of medical device software under EU MDR Rule 11.

EVErik Vollebregt

10:05 – 10:50

What Notified Bodies Expect from IVDR Performance Evaluation of Software IVDs

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Performance evaluation requirements for software IVDs.

MLMari Levula

10:15 – 10:50

Regulatory Strategy as a Market Access Engine: Lessons from Scaling Medical AI in European Healthcare

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Regulatory strategies for scaling medical AI products.

RHReetta Hintsanen

12:15 – 12:50

Translating EHDS Requirements into Concrete Software Design

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Applying European Health Data Space requirements to software development.

JWJanne West

12:15 – 12:50

The Future of European Diagnostics: What the IVDR Revision Means for Industry

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Potential implications of IVDR revisions for diagnostics manufacturers.

NKNelli Karhu

12:50 – 13:25

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

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Software bills of materials and medical device software design.

KMKrishnadev Moothandassery Ramdevan

12:50 – 13:25

How to Shepard Your IVDs Through the Tail of Legacy Devices Transition?

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Managing legacy IVD transition requirements.

MRMolly Rogers

13:25 – 14:00

Verify Before You Amplify - One Specialist's Field Notes on AI in Clinical Work

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Practical AI applications and verification in clinical workflows.

JMJari Martelin

13:25 – 14:00

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

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Maintaining IVDR certification and preparing for follow-up audits.

RWRina Wahlroos

15:00

Congress Ends

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End of the congress.

Medtech Compliance Forum by Aurevia & RAPS 2027

About This Event

Speakers

Medtech Compliance Forum by Aurevia & RAPS 2027

Program

Day 1Thursday, 11 February 2027

Registration, Coffee and Exhibition

Opening Words

A Smarter Lab: How Automation, Clinical Decision Support & AI Shape Our Future

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

What Makes or Breaks a Clinical Investigation?

Governance and Post-Market Monitoring of Healthcare AI

Real-World and Digital Evidence in Medical Device & IVD Regulation

Simulated Clinical Evidence - In Silico Clinical Trials: Regulatory Acceptance and Future Applications

AI Drift and the Lifecycle Management of Medical AI

Why CERs Still Fail: Lessons from NB Assessments

Key Components of Good Clinical Evidence for AI Devices

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

Deploy First, Prove Later? The Rise of Real-World Testing in Healthcare

CECP Requirements Meets Clinical Reality

Day 2Friday, 12 February 2027

Registration, Coffee and Exhibition

Mind the Gap – Navigating the Regulatory Metro Map

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

MDSW and Rule 11 - 101 Ways to Interpret a Rule

What Notified Bodies Expect from IVDR Performance Evaluation of Software IVDs

Regulatory Strategy as a Market Access Engine: Lessons from Scaling Medical AI in European Healthcare

Translating EHDS Requirements into Concrete Software Design

The Future of European Diagnostics: What the IVDR Revision Means for Industry

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

How to Shepard Your IVDs Through the Tail of Legacy Devices Transition?

Verify Before You Amplify - One Specialist's Field Notes on AI in Clinical Work

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

Congress Ends