Biography

Michael Righter is a Strategic Consultant with EBG Advisors, Inc. Mr. Righter has more than 12 years’ experience in regulatory compliance and Quality Management Systems for the medical device. He is a regulatory professional with extensive experience with FDA Class I and Class II medical device design and clearance in the United States and abroad. Mr. Righter has recently focused on clearance of mobile applications (software) and at-home medical device (hardware) solutions. He has also driven submissions for other international regulatory bodies to obtain legal marketing rights of software, systems and hardware. Mr. Righter maintains a watchful eye on corporate activities including Quality Management System compliance, and adherence to the various requirements. He has a proven track record of successful interactions with FDA.

Representative Experience

As the Director of Regulatory Affairs at AliveCor, Inc., Mr. Righter stepped into a burgeoning mobile health market. He overcame several hurdles facing the company including one of the first regulatory clearances of a mobile-app-based medical device.  He also was at the helm of Regulatory Affairs and Quality Assurance at iRhythm Technologies, Inc., where he led the charge for each of iRhythm’s successful 510(k) and other regulatory filings.

Mr. Righter started his professional medical device career developing innovative orthopedic implants for Acumed. While at Acumed, he co-initiated an in-house start-up called ARC Surgical. During his tenure at ARC, he created an ISO13485 and FDA compliant Quality Management System from the ground up, designed and launched an array of bio-absorbable implants for soft tissue and bone repair, and was involved in all aspects of the business from technical sales to cadaver lab training. His efforts help turn the business profitable within three years of formation, and ARC was quickly absorbed back into its parent company.

Mr. Righter holds a Bachelor of Science in Mechanical Engineering with several regulatory and quality certifications.

Education

  • University of Portland  (B.S.)
    • Mechanical Engineering