Manuela Schwegler

About

Profession

Scientific & Regulatory Expert, Biologist

Company

i.DRAS GmbH (HWI group)

Country

Germany
Interests

My interest in medical software

New requirements due to the new EU Medical Device Regulation 2017/745 regarding fulfillment of general safety and performance requirements for CE certification of medical software;

My skills in medical software

Clinical evaluation of stand-alone medical software, medical apps and active medical devices with embedded medical software, CE Marking strategy for stand-alone software and medical apps, post-market clinical follow-up study design;