Eric Henry

About 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 system 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 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.

Experience

1. Member, Board of Directors

   Quality Champions For Life

   Feb 2026 — Present

Education

• Wilmington University

  BS, Business Administration / Organizational Management

Skills

• Product Development
• Software Quality
• U.s. Title 21 Cfr Part 11 Regulation
• Verification and Validation (V&V)
• Iso 13485
• Quality Management
• Design Control
• Quality Assurance
• Quality System
• Quality Systems
• V&V
• Test Management
• Quality Auditing
• Iec 62304
• IT Audit
• Medical Devices
• Capa
• Internal Audit
• Process Improvement
• Qsr
• Test Planning
• Qms Remediation
• Software Verification
• 21 Cfr Part 11
• Test Strategy
• Computer System Validation
• Software Quality Assurance
• Change Control
• Csv
• Validation
• Testing
• Inspection / Audit Management
• Corrective and Preventive Action (Capa)
• U.s. Food and Drug Administration (Fda)
• Software Documentation
• Sdlc
• Fda
• V-Model
• Process Development
• Cross-Functional Team Leadership