About:
I am a Regulatory Expert within Medical Devices with extended knowledge within digital health solutions like apps and software for telemedicine, mobile health, telehealth, AI etc. This goes for CE-marking within EU and FDA 510(k) clearance in USA.

I have gained experience with a pragmatic approach to the regulatory requirements, which is essential when defining a regulatory strategy that is needs-driven, market-driven and competitive. 

In the same way I have several years experience consulting within regulatory challenges in relation to digitization of healtcare systems.

I have been involved in implementation and improvement of cetified quality management systems according to ISO 13485 and FDA 21CFR820. This applies in both small and large organisations in connection with development, production and delivery of physical medical devices, software, and apps.

The many years of experience as a development manager, project manager and not at least as a consultant in the development of medical devices are of great importance to the strategies and proposed solutions that I bring to the table.