Eric Henry

Leveraging more than 35 years of experience, I help medical device and digital health companies navigate the challenges that keep them up at night: FDA enforcement actions, regulatory compliance in emerging technologies, Quality Management System (QMS) remediation, and M&A risk assessment.

My operational skillset emphasizes the following:

• Global, multi-disciplinary, and multi-industry leadership, with a heavy focus on both establishment of and execution against strategic and functional goals;
• Establishment, defense, and remediation of Quality Management Systems (QMSs) in both global and domestic regulatory settings including effective interactions with regulatory authorities and notified bodies;
• Organizational process improvement initiatives;
• Methodical establishment and growth of high-performance organizations;
• Wide-ranging functional expertise in emerging technology medical devices (e.g., SiMD, SaMD) including AI/ML-enabled devices;
• Advising corporate management, boards, and public-private partnership leaders on regulatory requirements and compliance strategies;
• Execution of regulatory due diligence for M&A; and
• Application of global regulations, standards, and guidance in MedTech business operations.