Mike Larsen has substantial and broad experience, including executive level positions, with global life science companies spanning start-up environments to Fortune 200 companies.
Mike’s areas of expertise include Research and Development, Regulatory Affairs, Quality Systems and Clinical Studies for Class I through Class IV medical devices, pharmaceutical products and combination products. Standalone software products and embedded software represent a significant aspect of Mike’s related repertoire.
Several of Mike’s additional, associated skills include:
Pharmacovigilance processes
Medical Device vigilance
Global data privacy compliance, including USA Health Insurance Portability and
Accountability Act (HIPAA) requirements
International standards compliance
Intellectual property protection.
Mike is based in Wisconsin, United States of America.