Meet the Team
The Experts behind the success
Kristin M. Mortenson
President
Kristin Mortenson leads her consulting firm with over 30 years of combined experience in Research & Development, Quality, and Regulatory Compliance within the medical device industry. She specializes in project management for product development, integrating risk management (ISO 14971) and design controls. Her expertise spans design input and output, project planning, verification and validation, and regulatory compliance.
As a Certified Quality Auditor (CQA) since 2004, Kristin has extensive experience establishing, auditing, and improving Quality Management Systems (QMS) to meet FDA 21 CFR 820, ISO 13485:2016, European MDR, and Canadian MDR standards. She also conducts training seminars on cGMP and design controls and has a strong focus on implementing electronic Quality Management Systems (eQMS) for a streamlined, paperless approach.
Her technical expertise covers a broad range of medical devices, including wearable devices, endovascular catheters, orthopedic and spine implants, respiratory ventilators, surgical instruments, and software-based medical devices.
Erin Hughes
Vice President
Erin brings over a decade of experience in engineering and project management within the medical device industry, working with both in-house production and contract manufacturing. She holds a Master’s in Manufacturing Engineering from St. Thomas and is a certified Project Management Professional (PMP), reflecting her expertise in guiding complex projects to successful completion.
Erin thrives in process development, validation, and product design transfer into manufacturing, managing projects across multiple countries with a focus on manufacturing transfers. Her analytical mindset shines through her love for creating efficient spreadsheets and detailed Gantt charts.
Outside of work, Erin enjoys tackling home projects and relaxing with her two dogs, and her family.
Kelsey Rustin
Kelsey Rustin
Kelsey Rustin
Kelsey is a mechanical engineering leader with 13 years of experience across the aerospace and medical device industries. She holds an MS in Mechanical Engineering from Michigan Technological University and a BS in Mechanical Engineering from Marquette University. Kelsey has led complex projects from concept through verification, combinin
Kelsey is a mechanical engineering leader with 13 years of experience across the aerospace and medical device industries. She holds an MS in Mechanical Engineering from Michigan Technological University and a BS in Mechanical Engineering from Marquette University. Kelsey has led complex projects from concept through verification, combining technical rigor with thoughtful leadership and strong cross-functional collaboration. She is passionate about solving challenging problems, supporting innovative product development, and helping teams grow. Outside of work, she enjoys exploring the outdoors, traveling, cooking new recipes, and staying curious about the world around her.
Keith LeLand
Kelsey Rustin
Kelsey Rustin
Keith is a University of Minnesota trained mechanical engineer with 30 years of experience in medical device design, verification, and manufacturing. He has worked at several device start-ups and co-founded a company based upon a device that allows doctors to insert pediatric ear tubes in an office setting. A love of solving mechanical
Keith is a University of Minnesota trained mechanical engineer with 30 years of experience in medical device design, verification, and manufacturing. He has worked at several device start-ups and co-founded a company based upon a device that allows doctors to insert pediatric ear tubes in an office setting. A love of solving mechanical problems and tinkering in the shop have resulted in over 40 US patents and contributions to a number of successful commercial medical devices. Keith has been consulting since 2017, focusing on design and development. In his spare time, he enjoys riding and working on motorcycles, and being outdoors with his dog.