MDR Adventures

Thanks Hugo Huijs for some great posts in the last few weeks. We have some many talented people and therefore loads of exciting things happen Orikami . Coming month The Linkedin floor is mine, so let’s kick in with some MDR adventures.

Since we have a CE certified Medical product MS Sherpa and have great ambitions to release new products in different desease areas we are very eager to learn how to comply with MDR regulations. Since we already created the proper documentation for CE certification we learned that our current process is well in line with the new regulations.

The difference between, my previous medical devices development experience (HW/SW) and Orikami, we also have to prove that our medical claim is valid. MS sherpa does already have proof that the data that is being collected does provide clinical relevance for people with MS.

Together we are investigating new disease area’s like Alzheimer's disease. We develop software which we can make a relevant medical claim and therefore help our mission to provide personalised healthcare for patients.

We currently have different Digital BioMarkers (Digital Tests for patients) cognitive, mobility and several short term and long term memory tests available.

These test are currently used in studies in numerous dutch hospitals where people collect data at home. My role is to guide the product development team through delivering high quality software which is ISO:13485:2016 compliant and delivers all the proper documentation for MDR. I am really excited to help contribute the transition of digital health for all people around the world. Al lot of work has been done and loads of work is still needed to help with this transition.

Let me know if you have experience with MDR related products.

#quality #ehealth #mdr #training #orikami #datascience