MedCrypt Archives - Medical Design Sourcing

The FDA is issuing cybersecurity deficiency letters — here’s how to make sure you don’t get one

A former FDA reviewer shares insights into the depth and breadth of FDA cybersecurity deficiencies that could sink your device.

Naomi Schwartz, Medcrypt

[Image by Angelov via Stock.Adobe.com]

As of Oct. 1, 2023, the FDA enacted its Cybersecurity Refuse to Accept (RTA) policy, turning away any medical devices that do not meet its premarket and postmarket cybersecurity guidance. And earlier, in June 2023 the FDA released final guidance about the Electronic Submission Template and Resource (eSTAR) program which requires all relevant cybersecurity information to be completed, effectively signaling a new era of regulatory accountability.

With the FDA’s increased cybersecurity authority and resulting enforcement, medical device manufacturers must now comply with FDA mandates. In years leading up to recent regulations, the FDA used a more idiosyncratic and educative carrot approach, providing guidance and…

Emergo by UL, MedCrypt pair on cybersecurity

Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems.

Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand and meet the FDA’s requirements and those of other market regulators.

Get the full story on our sister site, Medical Design & Outsourcing.

MedCrypt acquires MedISAO in medtech cybersecurity deal

(Photo by Markus Spiske on Unsplash)

Healthcare cybersecurity company MedCrypt (San Diego) today announced the acquisition of Irvine, Calif.-based MedISAO, a cybersecurity information-sharing organization that works with the medical device industry.

MedCrypt is now offering MedISAO’s information-sharing analysis network for small and midsize business as well as its Cyber Protek software bill of materials (SBoM) and dependency vulnerability management tool. MedISAO’s founder, Daniel Beard, will also join the MedCrypt team in integrating and expanding the platforms.

Get the full story on our sister site, Medical Design & Outsourcing.