Evan Ammidown
With 5+ years of experience supporting regulatory clearance testing for Class II medical devices, Evan guides study design and statistical analysis for clinical trials out of our Boulder, CO, lab.
Experience
Evan Ammidown is the Engineering Manager for the clinical research team at Element Boulder, supporting on-human clinical trials of Class II medical devices. He oversees the full clinical trial lifecycle of vital sign monitors such as pulse oximetry/SpO₂, blood pressure, heart rate, and respiratory rate.
Evan has been working in the medtech industry for 5+ years and continues to expand his knowledge and expertise as he works towards his PhD in Materials Science. Throughout a clinical trial, whether it be local to Boulder or across multiple US sites, Evan leverages his expertise in calibration, regulatory strategy, and clinical research to produce documentation that guides engineering design and refinement of devices. He always ensures high-quality outputs that help to advance the next generation of medical devices.
Career Highlights
- Serves as a US Expert to 2 ISO joint working groups- JWG10 for pulse oximetry and JWG7 for non-invasive blood pressure.
- Presented sample size calculations and rationale to both JWG10 and the Open Oximetry Project, including international experts and regulatory body representatives.
- Authored sections of ISO 80601-2-61:2026.
- Oversaw multi-site clinical validation studies spread across multiple US labs.
- Created study designs for submission to regulatory bodies such as de Novo.
Qualifications & Credentials
Qualifications
- 5+ years of experience in regulatory clearance for Class II medical devices
Credentials
- Bachelor of Science in Chemical Engineering from Rose-Hulman Institute of Technology
- Master of Science in Bioengineering from the University of Colorado
Memberships
- ISO JWG10 for pulse oximetry
- ISO JWG7 for non-invasive blood pressure