Your Journey for certification and Market Access
One day in person with BSI regulatory experts to explore key EU requirements for medical technologies (MD, IVD, AI), understand common compliance pitfalls, and gain helpful information for market access. This event provides startups, established manufacturers, regulatory professionals with the knowledge, insights and networks needed for progressing with confidence.
Why Attend?
If understanding MedTech regulatory pathways is your priority, you will gain:
- Clarity on MDR and IVDR pathways: Understand key certification routes, requirements, and expectations for successful EU market access
- Effective engagement with a Notified Body: Learn how working with BSI can streamline your certification process and reduce delays
- Focused deep dives: Gain practical insights through dedicated breakout sessions on SaMD, IVDs, and drug-device combination products
Speakers
Breda Kearney – Regulatory Lead – Clinical Regulatory Lead Team, BSI
Sofia Palm – Regulatory Lead, BSI
Thomas Doerge – Global Head Active Implantable Medical Devices and SaMD, BSI
Michiel van Daalen – EIMEA Client Manager – Regulatory Services, Medical Devices, BSI
James Kerr – Technical Team Manager – IVD, BSI
Dilara Gumusbas Donida Labati – AI Technical Specialist , BSI
Theresa Jeary – Global Head Medicinal & Biologics, BSI
Roberta Brocardo – Technical Team Manager – Active Medical Devices, BSI
Magnus Olla – Senior Business Development Manager, Medical Devices – Nordics, BSI
Agenda
09:00 Walk-in & Coffee
09:15 Opening session – Presenting BSI
09:30 Regulatory Updates
09:50 Clinical Evaluation
10:35 BREAK
10:50 Structured Dialogue
11:20 QMS & ISO13485 (MDR/IVDR) – Preparation, stage 1 & stage 2 audit, lessons learned
11:50 Startup interaction with the NB
12:30 LUNCH
13:45 Workshops (select one of the workshops when registering)
- SaMD and AI: from Innovation to regulatory Compliance
- IVD Clinical Evidence
- Perspectives on Article 117 and Drug-Device Combinations
- Lessons Learned from Technical Documentation Pitfalls and insights on Active Medical Devices
14:45 COFFEE BREAK
15:00 Closing & Networking
15:30 End of meeting
About BSI
BSI about itself: BSI is a leading Notified Body for MDR, IVDR and Approved Body for UKCA. We offer certification services to place safe and compliant medical devices on the market: as independent market-leading experts in patient safety, we enable effective market access for medical technologies. We empower our clients to navigate the regulatory landscape – regardless of where they are in the medical device product development lifecycle. Website: www.bsigroup.com