Software Bill of Materials (SBOM) for FDA Submissions and post market Surveillance

PITTSBURGH, PA, USA, January 11, 2022 /EINPresswire.com/ -- Today, Vigilant Ops, an innovator in medical device cybersecurity and developer of the Software Bill of Materials (SBOM) automation platform InSight, announced a partnership with BeanStock Ventures of San Diego, California.

BeanStock Ventures is a medical device software product development organization with regulatory expertise. It is one of only nine FDA-Recognized 510(k) Third Party Review Organizations (3P510K), enabling the fast-track of medical devices for 510(k) clearance, which is a premarket submission made to FDA to demonstrate medical device safety and effectiveness. BeanStock’s designation provides medical device manufacturers with an alternative review process which can significantly reduce the average FDA wait time.

“Partnering with BeanStock Ventures enables one-stop shopping for medical device manufacturers looking for both pre and post market regulatory compliance support,” said Ken Zalevsky, CEO at Vigilant Ops. “Our InSight Platform automates the generation of the device Software Bill of Materials (SBOM) and the documentation to submit with the 510(k) application to FDA. Our InSight Platform also provides continuous monitoring and maintenance of the SBOM, enabling medical device manufacturers to adhere to FDA Postmarket surveillance requirements.”

“BeanStock Venture’s Software Product Development expertise allows us to approach execution strategically with our regulatory and product development expertise infused. Our team holds expertise in working with legacy software and creating new software to ensure a product platform can be built for cybersecurity.” said Shawnnah Monterrey, CEO at BeanStock Ventures.

The Vigilant Ops InSight Platform uses various techniques to interrogate medical devices and automatically generate SBOMs, which are then continuously monitored and updated. By leveraging natural language processing techniques and patented machine learning algorithms, vulnerabilities associated with device components are found and communicated in near real-time.
 

Founded in 2019, Vigilant Ops is an innovator in the medical device cybersecurity industry. Led by medical device cybersecurity experts with more than forty years of combined experience, Vigilant Ops provides medical device manufacturers and hospitals with unprecedented insight into device risk profiles, enabling proactive management of threats before they impact the quality of patient care.

For more information about Vigilant Ops or the InSight Platform, please visit our website at www.vigilant-ops.com

Matt Lentine
Vigilant Ops, Inc.
+1 412-704-4602
matt.lentine@vigilant-ops.com
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