E-health products, regulatory strategy and clinical testing

Webinar and One2One virtual meetings. Hosted from Oslo, Norway

June 02, 2021

12:00 - 15:30

Webinar and one2one opportunity to meet test facilities and clinical regulatory experts one2one. What does an e-health company need to know and consider from a regulatory and clinical perspective?

What does it mean to be an e-health company? With the changes in the EU regulations many software companies are finding a regulatory strategy difficult to navigate. Clinical evaluation is a very important part of that strategy so understanding the basic is key to moving towards compliance.

Nordic Proof especially invites companies developing e-health medical devices.

All partners of Nordic Proof will be available for one2one online meetings after the webinar. Also two of our speakers will be available for one2one to address your questions related to regulatory and clinical strategy of e-health products.

Even though a special focus will be on e-health and software based products any medtech company which need access to test facilities are much welcome to the webinar.

We also urge companies already in contact with Nordic Proof to benefit from this one2one opportunity.

 

Program (CET):

12:00 pm          Welcome and short intro to Nordic Proof and the program, Siri Stabel Olsen, Coordinator Nordic Proof

12:10 pm          Navigating the regulations for e-Health companies, Kami Faust, Regulatory Advisor at Norway Health Tech

 12:25 pm        Clinical Evaluation for Software as a medical device , Claudia Dannehl, Medical Device Manager at Link Medical

12:45 pm         An e-Health companies journey from concept to submission, Anders Aune, CEO at Picterus 

1:00 pm           Closing of webinar and start One2One meetings in separate online meeting rooms

3:30 pm           End program

 

Kami Faust: Making the regulatory determination of your solution or device is a critical step for any company within the e-Health arena. Kami will share invites and examples for what e-Health solutions would fall into the medical device category and what that means for you regulatory strategy. Kami will also give an overview of what clinical evaluation and investigation are and what they mean for your organization.
Claudia Dannehl: Clinical evaluations are mandatory for all medical device types. Claudia will share some insights to the basic requirements that apply for digital health and some hacks on how to achieve them. She will also provide some guidance on how to approach clinical investigations.
Anders Aune: An e-Health companies journey from concept to submission. An overview of Picterus’s pathway to submission for the EU CE Mark for a class IIa medical device software

Documents and Presentations

Presentations Nordic Proof Webinar

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