Naomi Schwartz, former premarket reviewer and consumer safety officer for the FDA, has been promoted to serve as Vice President of Services at Medcrypt, a cybersecurity solution provider for medical device manufacturers. In this new role, Schwartz will provide regulatory guidance to medtech companies to help them meet FDA cybersecurity guidelines and gain approval for their devices.
In its announcement, Medcrypt noted new regulatory actions including FDA’s announcement that is refusing to accept any medical devices that fail to comply with its mandatory pre- and post-market guidelines. “The urgency for prioritizing cybersecurity has never been more pressing, and many organizations are struggling to position themselves strategically to derive tangible business value from this imperative shift,” said Schwartz. “I’m eager to step into this VP role at Medcrypt to guide our customers toward success in the evolving landscape of medical device clearance and approvals. With our team of experts, Medcrypt is well-positioned to continue helping medical device makers navigate the regulatory landscape and embrace the importance of cybersecurity in their products.”
As Vice President of Services, Schwartz will play a pivotal role in supporting the company’s clients in all areas of cybersecurity compliance through its services, including:
- FDA Cybersecurity Filing Readiness Survey: This free assessment for MDMs helps gauge submission readiness with survey questions aligned with the FDA guidance, including RTA/eSTAR, and provides insights into the risks to acceptance.
- FDA Cybersecurity Filing Remediation: For MDMs who do not pass the FDA Filing Readiness Survey or have received an FDA refusal, Medcrypt’s experts can help identify gaps and create a prioritized plan to rectify issues.
- FDA Cybersecurity Submission Readiness: Aimed at MDMs with submissions either already under FDA review or planned for the near future, this service offers a comprehensive review using Medcrypt’s framework to ensure cybersecurity compliance.
- Hold Letter Cybersecurity Response: In the event of an FDA hold letter, Medcrypt provides guidance to navigate the response process effectively.
- CeQ: The Cybersecurity-enabled Quality System is Medcrypt’s most comprehensive consulting offering. Medcrypt provides regulatory-aligned cybersecurity templates to augment your existing Quality Management System (QMS). Complementary workshops assist your organization in both drafting submission-ready documentation and teaching you to properly maintain cybersecurity within your QMS on an ongoing basis.
“Our commitment to delivering top-tier services is driven by our desire to bridge the education gap in medical device cybersecurity. We understand that achieving compliance goes beyond offering a product; it requires supporting our clients in their people, processes, and technology efforts,” said Mike Kijewski, CEO of Medcrypt. “We’re excited to have Naomi in this role. With her FDA experience, her visionary approach will pave the way for success, ensuring that businesses not only meet the FDA’s stringent requirements but also thrive in an environment where cybersecurity is a fundamental business value.”