Calley A. Hardin

Business Unit Lead - Medical Devices

Calley A. Hardin joined Biologics Consulting as a Consultant (Medical Devices) in February 2009.

Calley came to Biologics Consulting with over 8 years of experience in various technical engineering roles, including 3 years of experience as a Biomedical reviewer at FDA in the Office of Device Evaluation, Division of General, Restorative and Neurological Devices, General Surgery Devices Branch. At FDA, Calley was involved in the review process for 510(k)s, IDEs and as lead reviewer for PMAs. Calley’s combination of industry and FDA experience positions her to provide clients with a specialized understanding of regulatory processes and the challenges they may encounter when interacting with the agency.

Calley holds a BS in Biomedical and Electrical Engineering from Vanderbilt University.

Calley served as a Consultant / Senior Consultant on the Medical Device Team for 12 years. As the Business Unit Lead for the Biologics Consulting Medical Device Team, Calley is responsible for:
• Business development including new client intake, client satisfaction and ensuring that we remain a consulting firm of choice by reputation in the medical device community.
• Managing the current device team members, recruit new talent, and improve all team processes.

Education

BE, Biomedical and Electrical Engineering, Vanderbilt University, Nashville, TN (2000)