Our Team
Meet the experienced regulatory and quality professionals behind Highland Biomedical.
Brian Intoccia
Managing Director
Quality Systems, Design Quality Assurance, Systems Engineering, Combination Product
Josh Donahey
Director, Operations
Quality Systems, Design Quality Assurance, Project Management, IVD, SaMD/SiMD, Wearables, Device, Combination Product
Sarah Derr
Software Development Consultant
Product and Project Management, Software Development Life Cycle/IEC 62304, Clinical and Medical Informatics
Todd Etzel
Principal Software Development & Cybersecurity Consultant
FDA Cybersecurity/TIR57, SaMD/SiMD, Software Development Life Cycle/IEC 62304/TIR45, Risk Management/ISO 14971
Adam Heroux
Regulatory Affairs Consultant
Regulatory Affairs, Post Market, Quality Systems, SaMD, Digital Therapeutics, Information Security, Healthcare Compliance
Judith Frontin
Mechanical Systems and Engineering Consultant
Mechanical, Systems Engineering Medical Device, IVD, Combination Products
Garrett Green
Software Development & Cybersecurity Consultant
Software Development Life Cycle/IEC 62304, FDA Cybersecurity/TIR57, Risk Management/ISO 14971
Work With Us
Ready to benefit from our team's expertise? Let's discuss your regulatory and quality needs.
Contact Us