AMDD was brought into Endotronix following the early-prototype stage, providing staff augmentation after their first tranche of monies, first employee with any level of medical device experience; building executive team, and engineering teams, defining next generation products and services, leading teams and working as a working manager. Built System Engineering Team, rolled out requirements management tool (Jama,) Design History File/Technical Dossier management, created Risk Management system. Directed product Verification and Validation, submittals for clinical investigation in Ireland and Belgium, first in man clinical site evaluation, led physician training.

FDA OMA Approval: 2024   |   Acquisition: 2024 by Edwards Life Sciences

Applied Services

• Staff Augmentation
• Regulatory Affairs
• Systems Engineering
• Compliance Engineering
• Electronics Design
• Animal Testing
• Physician Training
• Risk Assessment
• IP Management