Maren Nelson

M Nelson Consulting

My goal is to help create affordable healthcare solutions that improve patient outcomes. I am an experienced professional in the use of risk management to create and improve processes, as well as the development and regulatory approval of medical devices through the entire product life-cycle.

I understand the regulatory requirements, and how to create compliant processes that add business value. I have experience in process improvement and training from R&D and Quality perspectives. As an example, I changes Document Control processes to support regulatory submissions. This helped the project team and reduced document revisions.

My medical device experience includes external defibrillators and pacemakers, multi-parameter patient monitors, medical software, sterilizable accessories, rechargeable batteries and chargers for medical products, and AEDs (Automated External Defibrillator). I am PMP certified.