Kristin M. Mortenson

Kristin M. Mortenson has held a variety of roles in the medical device industry since 1995. Kristin M. started as the President & Founder of Nirin Development in 1995, and held a Head of Quality position at Preceptis Medical, Inc. from 2012 to 2011. During this time, they also worked as a Consultant for Canopy Medical, LLC. In 2014, they were the Vice President of Quality and Product Development at EmboMedics. From 2015 to 2017, they were the QA, RA and Development Contract Head of QA/RA and Product Development Support at RxFunction, Inc., where they established an ISO 13485:2016 and FDA QSR compliant QMS using Greenlight.guru. Kristin M. also held a Quality Consultant position at Uromedica, Inc. from 2015 to 2017. In addition, they were an Advisor at the University of Minnesota from 2010 to 2012, and a VP Regulatory and Quality Assurance at Alexandria Research Technologiies from 2012 to 2014. Most recently, they have been the Director of Quality and Regulatory at Marblehead Medical since 2018.

Kristin M. Mortenson obtained their Bachelor of Mechanical Engineering (BME) degree from the University of Minnesota between 1983 and 1988. In October 2014, they obtained a Certified Biomedical Auditor certification from ASQ, and in October 2004, they obtained a Certified Quality Auditor certification from ASQ.