Kristin Merrill Mortenson

Greater Minneapolis-St. Paul Area United States

Medical Device Product Development, Project Management and Quality System Consultant

Medical / Health Care / Pharmaceuticals

I specialize in medical device engineering, and have over 27 years of combined experience in R&D and Quality / Regulatory Compliance in the device industry. I specialize in project management of product development projects utilizing design control steps with integrated risk management. Expertise includes design input / requirements, design output, project planning, design reviews, verification and validation protocols and reports. Additionally, as a Certified Quality Auditor (CQA) since 2004, I establish, audit and improve quality management systems in compliance with FDA QSR, ISO 13485, and ISO 9001 as well as OUS regulatory requirements such as the MDD Essential Requirements 93/42/EEC ...