An interactive talk, which will create an overview of how to improve the viability of academic development by considering regulatory pathways, quality management and clinical requirements from the early beginning.

Other questions answered during the talk:

• What is a medical device?
• What is required to get it on the market?

By Lea Hokland, Medidee

Senior Associate Lea Hokland has specialized in medical devices since 2011 and is handling the daily operations of Medidee Services Scandinavia (www.medidee.com ) – a European consultancy company assisting medical device and IVD device manufacturers from idea to certification.

Prior to doing consultancy, Lea was QA/RA manager in two different start-up companies (one of them as co-founder) and did research in the orthopaedic and hematologic areas. Her background in medical devices comprises regulatory affairs, quality management, and clinical affairs for both high-risk and in vitro diagnostic medical devices.

Lea has a broad experience from clinical research and academia and provides an interface between these and the device industry.  She holds a Ph.D. in Medicine, and a M.Sc. in human biology.

Registration: https://auws.au.dk/ready_to_invent/