MIAMI, Fla., (July 1, 2024) – MedSec, a leading medical device security services firm, announced today the addition of Matthew Hazelett as chief regulatory officer. Hazelett comes to MedSec with almost a decade of experience at the Food and Drug Administration (FDA). He will be joining the compliance team, focusing on guiding clients to meet and exceed regulatory requirements. He will also be focused on direct training initiatives to build a greater knowledge base across the industry and set manufacturers up for success in developing and maintaining more secure medical devices.
“We are thrilled to welcome Matt to the MedSec team as our new chief regulatory officer,” said Michelle Jump, chief executive officer, MedSec. “With his invaluable experience at FDA, Matt brings a wealth of regulatory knowledge and insights that will be instrumental in helping MedSec’s clients to navigate the ever-changing and complex regulatory landscape. I have always been impressed by Matt’s commitment to ensuring that medical devices meet the highest standards of safety and effectiveness. That commitment is an ideal fit for the MedSec culture and our approach with our clients.”
In his most recent position, Hazelett served as the Cybersecurity Policy Analyst in the Office of Product Evaluation and Quality (OPEQ). His role focused on premarket and postmarket cybersecurity policy development and implementation across the clinical review offices including the recent requirements under Section 524B of the Food, Drug, and Cosmetic Act and 2023 final premarket guidance. He also served as a Digital Health Center of Excellence Program Director for the OPEQ Cybersecurity Focal Point Program.
“Throughout my career at FDA, I sought to strengthen FDA's oversight of medical device cybersecurity,” said Hazelett. “Now, I'm excited to join MedSec to help manufacturers build a culture of cybersecurity to meet or exceed FDA's and other regulators’ statutory requirements and guidance.”
Hazelett started at FDA in 2015 as a biomedical engineer within the Implantable Electrophysiology Devices Branch (IEDB) at the Center for Devices and Radiological Health (CDRH). His review areas included pacemakers, defibrillators, leads, and supporting devices (programmers, home monitors, etc.). During his time at FDA, he developed a review focus in cybersecurity, participates in cybersecurity guidance development, and supports cybersecurity vulnerability assessments and premarket reviews across CDRH. Before joining FDA, he worked for a medical device research and development company in New Hampshire as a test engineer and then test manager overseeing device verification and validation testing.