08:45 - 16:00
Oslo Science Park
What is a clinical evaluation, how do you conduct it and why do you need clinical data for medical devices?
Under the EU project Cross4Health we welcome you to a hands-on workshop addressing these questions. Learn from our experts about how to conduct clinical evaluations and investigations, and who is involved in the processes. Familiarize yourself with various study designs for different products and stages of development. Engage with our experts Janette Benaddi and Louise Olliver from Obelis, discuss, exercise in groups and test your knowledge.
Janette Benaddi is a specialized trainer and consultant for the medical device industry with more than 25 years of practical experience, especially in gathering clinical data. She has successfully spoken at conferences and given training to organisations worldwide. Not only has she a medical background with a PhD in Health Sciences, she also has a very entrepreneurial mindset.
Louise Olliver has more than 30 years of experience in regulatory affairs and quality management in the fields of medical devices, in vitro diagnostics and pharmaceuticals. As a member of the EU Technical Committee (Quality Management Systems and Risk Analysis for Medical Devices) she contributes to reviews and revisions of EN ISO 13485 and EN ISO 14971. Louise speaks at professional conferences and delivers bespoke in-house training.
Obelis is an internationally known consultancy on EU regulations, supporting companies through documentation review, product registration and legal representation on their way to the EU Market. This workshop is also arranged in close collaboration with Nordic Proof, a premium network of public health tech testing facilities in the Nordics and thereby your potential entry door.
Following the workshop, Janette and Louise from Obelis as well as Siri Stabel Olsen from Nordic Proof will be available for private meetings (15min each).
Regarding the scheduling, please indicate your wish when registering for the event. You will be contacted by Claudia from the Norway Health Tech team. Feel free to contact her in case you have questions or need further information.
This event is organized within the EU funded project Cross4Health.
(The Cross4Health project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 731391 .)