Meet the Team

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 QSR, 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.

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 spouse.