Mike has helped dozens of medical device, pharma and healthcare delivery companies secure regulatory clearance and approval for their products and services, with a particular focus on digital health solutions.
He has obtained FDA clearance for mobile applications, at-home medical device solutions, and software as a medical device (SaMD) for organizations including: iRhythm Technologies, AliveCor, DreaMed, Eko Devices, and Sparo Labs. He has also led regulatory submissions of software, systems and hardware to international regulatory bodies to receive market authorization such as CE Marking in the European Union.
In his current role as Head of Regulatory and Quality, Mike is leading an innovative compliance strategy that enables customers to implement the BrightInsight Platform with minimal disruption and regulatory risk.
Prior to joining BrightInsight, Mike was Principal of Regulatory Affairs at his consulting firm Righter Consulting Group, LLC where he engaged 35+ companies to drive regulatory and quality system objectives.
Mike holds a Bachelor of Science in Mechanical Engineering from the Willamette School of Engineering at University of Portland with several regulatory and quality certifications including RAC and ISO13485 Lead Auditor.