MedSec Hires Chief Regulatory Officer

MIAMI, July 1, 2024 /PRNewswire/ — MedSec, a leading medical device security services company, today announced the addition of Matthew Hazelett as chief regulatory officer. Hazelett joins MedSec with nearly a decade of experience in the Food and Drug Administration (FDA). He will join the compliance team with a focus on advising clients on meeting and exceeding regulatory requirements. He will also focus on face-to-face training initiatives to build a greater knowledge base in the industry and ensure manufacturers’ success in developing and maintaining safer medical devices.

“We are delighted to welcome Matt to the MedSec team as our new Chief Regulatory Officer,” he said Michelle JumpCEO of MedSec. “With his invaluable experience at the FDA, Matt brings a wealth of regulatory knowledge and insights that will be instrumental in helping MedSec customers navigate the ever-changing and complex regulatory landscape. I have always been impressed with Matt’s commitment to ensuring that medical devices meet the highest standards of safety and effectiveness. This commitment fits perfectly with MedSec’s culture and our approach to our customers.”

In his most recent position, Hazelett served as a cybersecurity policy analyst for the Office of Product Evaluation and Quality (OPEQ). His role focused on the development and implementation of pre-market and post-market cybersecurity policies in Clinical Review Offices, including the recent requirements outlined in Sec. 524B Food, Drug and Cosmetic Act and final pre-market guidance for 2023. He also served as program director of the Digital Health Center of Excellence for the OPEQ Cybersecurity Focal Point program.

“Throughout my career at the FDA, I have worked to strengthen FDA’s oversight of medical device cybersecurity,” said Hazelett. “I am excited to join MedSec to help manufacturers build a culture of cybersecurity to meet or exceed regulatory requirements and guidance from the FDA and other regulatory authorities.”

Hazelett joined the FDA in 2015 as a biomedical engineer in the Implantable Electrophysiology Devices Branch (IEDB) at the Center for Devices and Radiological Health (CDRH). His areas of review included pacemakers, defibrillators, cables, and ancillary devices (programmers, home monitors, etc.). During his time at FDA, he developed a cybersecurity-focused review, participates in the development of cybersecurity guidance, and supports cybersecurity vulnerability assessments and premarket reviews at CDRH. Before joining the FDA, he worked at a medical device research and development company in New Hampshire as a test engineer and then a test manager supervising device verification and validation tests.

About MedSec, LLC

Most cybersecurity companies operate in a variety of industries. MedSec is different because it focuses solely on medical devices and healthcare. We provide healthcare organizations and medical device manufacturers with comprehensive cybersecurity expertise – including technical expertise, regulatory guidance, implementation and technical services for medical device manufacturers. To contact our subject matter experts, please send an email (email protected) or visit us at www.medsec.com.

Only contact with the media
Michelle JumpGeneral Director
(email protected)
medsec.com

SOURCE MedSec LLC