- Tämä tapahtuma on mennyt.
MDR Essentials and the Changing Regulatory Landscape in EU
Where: On-line or SparkUp in ElectroCity atTykistökatu 4 B, Turku
When: 9.12.2020 9:00~12:00 Finnish time
How: Register here. The registration is open until 6.12.2020.
We’re already living the era of the new EU medical device regulations MDR & IVDR, but there are still preparations to be done by the European Commission, manufacturers and other economic operators in the field of health tech. The official time for MDR transition is May 2021 and for the IVDR it is May 2022. What are the most essential regulatory topics to focus on and how does the certification process look like, when you get there? Join this HealthTurku event to hear the updates.
08:30-09:00 On-site registration, coffee and savory pie
09:00-09:45 Medical Device Regulatory Essentials in Health Tech, Heikki Pitkänen, Lean Entries
09:55-10:40 Preparing for the MDR & IVDR (with Sneak Peek into Software and Combination Products), Heikki Pitkänen, Lean Entries
10:50-11:05 The role of Notified Bodies in the certification process, Aliisa Siljander, Eurofins Expert Services Oy
11:10-11:25 Lessons learned in preparation to MDR era, Karri Airola, BonAlive Biomaterials Ltd
11:25-11:40 The Change from IVD Manufacturer’s Perspective, Janne Koskinen and Mikko Tasanen, ArcDia Ltd
11:40-11:50 Co-Creation in Healthcare, Case: Terttu, Janne Lahtiranta, Turku Science Park Ltd
11:50-12:00 -> Discussion continue ~12:00 with on-site salad lunch
The event is organised by Turku Science Park Ltd, is free of charge but requires registration. For more info please contact Hanna Halme.
Recommendations related to the Covid situation are followed. If you have even a small runny nose or have traveled to a risk area within 2 weeks, it is not appropriate to attend the on-site event. Masks are available at the venue.