Printed: Aug. 30, 2022 at 11:00 AM EDT
Naomi will likely be becoming a member of the main supplier of medical gadget cybersecurity following a 6.5-year profession on the U.S. Meals and Drug Administration
SAN DIEGO, Aug. 30, 2022 /PRNewswire/ — MedCrypt, Inc., the proactive cybersecurity resolution supplier for medical units, right now introduced Naomi Schwartz as their new Senior Director of Cybersecurity High quality and Security. Previous to MedCrypt, Naomi was a premarket reviewer and client security officer for the U.S. Meals and Drug Administration (FDA) within the Workplace of In Vitro Diagnostics and Radiological Well being (OIR). With over 20 years of programs engineering expertise, Naomi’s main focus at MedCrypt will likely be to steer evaluation of cybersecurity designs for medical units and assist medical gadget producers (MDMs) optimize their cybersecurity framework to satisfy tips set by the FDA.
Throughout her time with the FDA, Naomi accredited the software program and cybersecurity for the world’s first regulated Automated Insulin Dosing (AID) System and created Class II pathways for the three main elements of AID programs, a game-changer for supporting sufferers with insulin-dependent diabetes. She was additionally the FDA’s liaison on requirements for cybersecurity of diabetes units and for EMC of In Vitro Diagnostic (IVD) units. Previous to that, Naomi spent 15 years supporting the Division of Protection as a contractor, specializing in radar system necessities and efficiency analyses, system design, and unbiased verification and validation. Moreover, all through her profession, she has obtained a number of business achievement awards, together with:
- The Heart for Gadgets and Radiological Well being (CDRH) Plain Language Award
- The CDHR Group Recognition Award for the Pressing 11 Response Crew
- The Excellent Buyer Service Award from the CDRH for her time with the FDA
- The Samuel J. Heyman Service to America Medal: “Administration Excellence: Courtney Lias, Stayce Beck and the FDA Synthetic Pancreas Crew (2017)”
“Interoperability is the way forward for medical units, and of healthcare total, and I am very excited to affix MedCrypt to develop instruments and providers for producers that can enhance their cybersecurity processes,” mentioned Naomi Shwartz, MedCrypt’s new Senior Director of Cybersecurity High quality and Security. “MedCrypt is doing such necessary work and I am wanting ahead to advancing the general public well being mission by offering safety options that guarantee sufferers and healthcare suppliers have entry to world-class units.”
In her function at MedCrypt, Naomi will lead analyses of cybersecurity designs for medical units and assist MDMs optimize their cybersecurity implementations. She may also consider producer and cybersecurity processes to develop instruments that can enhance the combination of cybersecurity into high quality administration programs and scale back the burden and uncertainty of postmarket administration.
“Amid the rise in cybersecurity wants throughout the medical business, we’re thrilled to welcome Naomi to our increasing group,” mentioned Shannon Lantzy, Vice President of Consulting at MedCrypt. “Her earlier expertise on the FDA, in addition to a number of roles in programs engineering, will assist our shoppers speed up their innovation pipeline whereas lowering cybersecurity threat and uncertainty.”
“Within the years that I’ve identified Naomi, I’ve seen the affect she’s had on the best way we method cybersecurity via her work with two of the most important authorities safety groups within the nation,” mentioned Seth Carmody, MedCrypt’s Vice President of Regulatory Technique. “Her expertise with the FDA will assist orient MedCrypt’s methodology to supply gadget producers with a balanced method to cybersecurity to realize well timed, safety designs with out compromising security.”
Naomi is becoming a member of MedCrypt alongside Jamell Pentecost, who was just lately introduced as MedCrypt’s Senior Director of Product Safety Companies together with Ken Hoyme, who joined MedCrypt’s Advisory Board. MedCrypt at present supplies enhanced security measures and providers for seven of the highest 10 medical gadget producers in addition to startups and mid-sized corporations.
MedCrypt is the primary agency to mix cybersecurity know-how merchandise with administration consulting, choice science, and regulatory technique that’s 100% centered on supporting medical gadget producers. MedCrypt has raised greater than $9.4 million in funding up to now with participation from Eniac Ventures, Part 32, Y Combinator, and extra. For extra, please go to www.medcrypt.com.
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