HFE Regulatory Session: Clinical Evaluation Under MDR & FDA
Join us for a first-time MDR and FDA regulatory deep dive in Estonia on June 19 from 9:00 to 13:00. By participating, you will prevent costly compliance errors and accelerate time-to-market by improving your understanding of approval pathways and clinical evaluation processes.
The event is ideal for SMEs manufacturing medical devices and ecosystem stakeholders involved in the clinical evaluation processes to ensure products meet regulatory requirements and can be placed in the EU and US markets.
The event is in English and on-site. Register now, as the seats are limited. The organizer reserves the right to review registrations to ensure the maximum number of relevant companies at the event.
Agenda:
09:00 - 09:15 Doors open & registration.
09:15 - 09:25 Welcome to the event: opening words by Health Founders Estonia.
09:25 - 11:30 “Clinical evaluation under MDR and FDA: regulatory expectations and practical insights.” Keynote by Matthew DiFranco.
11:30 - 12:00 Break.
12:00 - 12:30 The role and processes of the ethics committee in conducting clinical trials (focus on MDR and IVDR devices). Presentation by Urmeli Katus (Senior Methodologist and Head of the Center for Evidence-Based Practice at the University of Tartu).
12:30 - 13:00 When should the supervisory authorities be informed about conducting a clinical trial? Presentation by the Estonian State Agency of Medicines.
13:00 - 13:15 Networking and end of the event.
🚨1:1 Session with Matthew DiFranco.
We are offering up to 6 companies the opportunity for 1:1 individual office hours (max 20 minutes per company) with Matthew DiFranco. Please indicate your interest while registering! To be selected for the office hours, a company must have a TRL level 3, along with a clearly defined initial description of the intended purpose of the medical device to be developed. Selected startups will receive a separate email confirming their selection and the operation details of the office hours.
The HFE program is funded by the EU through Enterprise Estonia, in collaboration with Startup Estonia, to build a strong, globally competitive health tech ecosystem in Estonia.
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About the speakers:
Matthew DiFranco is a leader in healthcare innovation with over 15 years of international experience in AI-driven medical imaging, digital pathology, and medical device development. His work encompasses radiology AI, machine learning research, nuclear medicine, and pre-clinical imaging.
Most recently, he served as Chief Scientific Officer at ImageBiopsy Lab, a Vienna-based startup providing validated AI solutions for musculoskeletal radiology. In this role, Matthew led the FDA and MDR clinical validation strategy for their AI software as a medical device (SaMD), managed important scientific partnerships across academia, pharma, and medtech, and drove innovation scouting to identify emerging applications of AI in medical imaging.
Urmeli Katus is the Senior Methodologist and Head of the Center for Evidence-Based Practice at the University of Tartu.