May 1-3, 2017 • San Diego, California
Maren’s goal is to help create affordable healthcare solutions that improve patient outcomes. She is 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.
Maren understands the regulatory requirements, and how to create compliant processes that add business value. She have experience in process improvement and training from R&D and Quality perspectives. As an example, Maren changes Document Control processes to support regulatory submissions. This helped the project team and reduced document revisions.
Maren’s 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). She is PMP certified.