Kristin M. Mortenson
Product Development, Quality and Regulatory Affairs
Kristin has been helping innovators get their product ideas from concept to regulated market clearance for over 30 years. She is a leader in Research & Development, as well as Quality and Regulatory Affairs in the medical device industry. Starting as a design and development engineer, she moved on to project management, and implementation of Quality Management Systems (QMS). Her projects medical device development are conducted in accordance with ISO 13485, 21 CFR 820 with integrated compliance to all applicable standards and regulations such as IEC 62366 usability engineering, 14971 risk management, and IEC 62304 software lifecycle. Product experience includes FDA class II and III classified devices, including; radio-frequency (RFID) device (via FDA De Novo process), software-only devices (PACS – picture archival and communications systems), wearable medical devices, endovascular catheters, hand held IVDs, electromagnetic navigational bronchoscopy (ENB) devices, orthopedic & spine implants and instruments, surgical - general and laparoscopic instruments & accessories, single use & reusable devices, combination (drug/device/biologic), respiratory ventilators, vascular catheters and implants, cardiopulmonary diagnostic systems, urological catheters & implants, , enteral feeding pumps and tube/catheters (nasogastric, gastric and jejunal implants), and otolaryngology / ear, nose and throat (ENT) devices.
As a certified auditor by ASQ (America Society for Quality) since 2004, she also audits and improves QMS (quality management systems) in compliance with international standards and regulations. Her focus has been on the implementation of electronic, paperless QMS companies. She holds a Bachelor of Mechanical Engineering from the University of Minnesota.