Medical device equivalence and its role in device approval under the MDR
Medical device equivalence and its role in device approval under the MDR
Tue, Feb 7, 2023 7:00 PM GMT (+00:00)
Free
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MDR Fast Track Service: How to enable medical device market entry
Join to hear an insider’s view on medical device market entry and find out more about an MDR Fast Track service by Innokas Medical.
By Health Talks
When and where
Date and time
Location
Online
About this event
Concept:
Welcome to the next event from the Health Talks series - health, life sciences and entrepreneurship talks organised by Aalto University, Health Design, Health Hub Tampere, HealthTurku, Healthtech Finland, HiLIFE, Kuopio Health, Terkko Health Hub, OuluHealth and Upgraded - Health Startup Association of Finland.
What:
In this Health Talks event, you will hear about an MDR Fast Track service launched by Innokas Medical. The service enables medtech companies to outsource the regulatory burden, focus on their core, and reach profitable and growing business faster than via the traditional route. You will learn how to navigate the industry’s complex regulatory environment in new ways and gain a deeper understanding of the service.
Innokas Medical’s expert, Pekka Pohjosaho, will tell you what the MDR Fast Track means in real life, how to evaluate whether the service is a match for you and what steps to take to get started.
This event is jointly organized by OuluHealth and Innokas Medical.
Agenda:
10:00 – 10:05 Opening words
10:05 -10:50 MDR Fast Track Service - How to enable medical device market entry with reasonable effort, Pekka Pohjosaho / Innokas Medical
10:50 – 11:00 Q & A
11:00 Closing words
Speaker:
Pekka Pohjosaho - Head of Quality and Regulatory at Innokas Medical
Pekka is an experienced Quality and Regulatory professional with a long history of working in the medical device domain. Pekka has deep practical knowledge of applying the various requirements in the field, such as ISO 13485, ISO 14971, IEC 61010-1, IEC 62366, IEC 62304, MDSAP and MDR as well as hands-on experience in working with R&D projects of AIMD, MD and IVD products as QA/RA specialist, project manager, usability engineer and software quality engineer. Currently, leading the Innokas QARA team Pekka has a front-seat view of the development and challenges of today’s Medical Device industry.
How:
The event will take place online. A Zoom link will be sent after registration. It can be found in the confirmation receipt you receive from the Eventbrite at the very bottom.
Notes:
The event will be recorded and later shared publicly.
For more info check the Health Talks webpage: https://terkko.fi/health-talks/
Registration data is controlled by Terkko and shared with other Health Talks partners.