Health Talks @HealthHUB: Demystifying medical regulations
Upgraded and HealthHUB welcome you to
Health Talks @HealthHUB: Demystifying medical regulations!
During the afternoon we will shed light on the mystical world of medical device regulations (MDRs) and give you concrete tools that help you deal with regulations now and in the future. We summon you, health/wellness/medical startups & companies, researchers, students, and professionals to join us to learn and network together!
- Merja Hiltunen, Senior Medical Officer from Valvira, will educate us on the core differences between ‘wellbeing’ devices and medical devices and about the transition into the new Medical Device Regulations that come into force in 2020.
- Petri Pommelin, Development Manager from the Tampere University Hospital RDI Center, will speak about clinical evaluation of medical devices. Petri Pommelin is also the author of “The Survival Guide to EU Medical Device Regulations”.
Tools, spells and sidekicks:
- Lean Entries will showcase their Regulatory Runway services, which help you to identify the correct medical device category for your product.
- CompliancePal will show you how their service assists in considering and integrating compliance aspects into your software already in the development phase.
- To complete the event, regulatory consultants pitch their services to you and welcome you for networking at their mini stands!
12:30 – 13:00 Coffee
13:00 – 13:05 Opening, Upgraded and HealthHUB
13:05 – 13:30 Is it too late for an MDR transition plan? Merja Hiltunen, Senior Officer (Medical), Valvira
13:30 – 14:00 Clinical evaluation, Petri Pommelin, Development Manager, Tampere University Hospital RDI center
Two presentations of digital tools for regulatory purposes:
14:00 – 14.15 Regulatory know-how and compliance in minutes, Heikki Pitkänen, Lean Entries
14:15 – 14:30 Monitor and improve regulatory compliance of medical software with every commit, Vlad Stirbu, CompliancePal
14:30 – 15:00 Regulatory consultants pitch their services
15:00 – 16:00 Mini stands and networking
Venue: Finn-Medi 5 building, Biokatu 12, 1 st. floor, Tampere
The Health Talks event series is a joint effort by Upgraded, Health Capital Helsinki, Health powered by A Grid, NewCo Helsinki and Terkko Health Hub.