MIAMI, July 1, 2024
/PRNewswire/ -- 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.
About MedSec, LLC
Most cybersecurity companies work in a variety of industries.
MedSec is different, focusing exclusively on medical devices and
healthcare. We provide healthcare delivery organizations and
medical device manufacturers with a holistic knowledge of
cybersecurity - including technical expertise, regulatory guidance,
implementation, and technical services for medical device
manufacturers. To connect with our subject-matter-experts,
email info@medsec.com or visit us
at www.medsec.com.
Media Contact Only
Michelle
Jump,
CEO
info@medsec.com
medsec.com
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SOURCE MedSec LLC