Laura Hargis, Senior Regulatory & Quality Specialist
As a Paramedic in the San Francisco Bay Area, Laura has seen, and worked, just about every type of medical emergency there is. She moved to Colorado in 1994 with her husband, where she started working in the medical device development world, bringing a unique perspective to the quality and safety of medical device design by understanding how the devices are used, and misused, in the field. She started her own company in 2013, Hargis Consulting, LLC, doing regulatory and quality work for medical device design companies, assisting in writing, and setting up Quality Management Systems, as well as doing internal audits as a certified ISO 9001 and ISO 13485 auditor. During that time, she helped 3 start-up companies get their quality system certified on their first try.
Laura currently has several professional certifications, including ISO 13485 Lead Auditor, MDSAP, and EU MDR auditor.