Latest
Industry News

Recommendations to Address Cybersecurity in Medical Devices PITTSBURGH, PA, USA, September 27, 2023The United States Food and Drug Administration (US FDA) issued the final version of their guidance document titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions – Guidance for Industry and Food and Drug Administration Staff” on September 27, 2023 (referred to as Premarket Guidance or the guidance in this summary). This important guidance…

PITTSBURGH, PA, USA, January 5, 2023/EINPresswire.com/On December 29, 2022, United States President Joe Biden signed into law the $1.7 trillion federal government spending package, officially avoiding a government shutdown. “What this means for the Medical Device Manufacturer community is that FDA now has legal authority to require specific cybersecurity related documentation starting 90 days from the signing of the bill.  By (or before) the end of March 2023, they must be prepared to su…

It’s a rare day if you don’t see a headline about a data breach or ransomware crippling a business or the supply chain. Websites are defaced, personal and financial information stolen, and even medical information is at risk for theft and improper sharing. Software once thought secure is now at risk more than ever as malicious insiders and state sponsored hacking have taken the forefront of electronic espionage and harmful data dumps. It’s become so prevalent the US government is working …

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 prema…

Last week, CISA (the U.S. Cybersecurity and Infrastructure Security Agency) issued an advisory about critical vulnerabilities in embedded software that opens the door to possible security breaches. No breaches have been reported to date, but the potential impact spans multiple industries, including healthcare. This short summary discusses how SBOM can help manufacturers respond and take action. SBOM Can Help with Vulnerability Discovery The Software Bill of Materials (SBOM) has been get…

As part of the response to recent hacks, the United States House of Representatives voted on and passed the DHS Software Supply Chain Risk Management Act of 2021 on October 20, 2021, by a vote of 412-2. The Act covers both new and existing contracts with the Department of Homeland Security (DHS). As a Condition on the Award of Contracts Contractors must submit a bill of materials, defined in this Act as “a list of the parts and components (whether new or reused) of an end product or ser…