Thirdwayv and Medcrypt have reached an agreement to collaborate on advancing cybersecurity and interoperability standards within the connected medical device sector.
This alliance aims to meet the growing need for comprehensive cybersecurity throughout the lifecycle of medical devices, in response to evolving regulatory and operational requirements.
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It will enable the delivery of integrated solutions designed to assist the manufacturers of medical devices in incorporating security features early in the development process, ensuring ongoing compliance, and documenting cybersecurity measures for regulatory submissions.
It will also facilitate the provision of secure over-the-air (OTA) software updates for connected devices.
Thirdwayv provides secure connectivity and cryptographic identity Software Development Kits (SDKs), which claim to have been vital in establishing wireless cybersecurity protocols, including those for US Food and Drug Administration (FDA)-cleared connected diabetes management systems controlled via smartphone control.
On the other hand, Medcrypt offers a platform that allows manufacturers to recognise, evaluate, and address vulnerabilities while helping to streamline regulatory compliance.
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By GlobalDataThe partnership is set to offer a verified security and compliance framework for medical device manufacturers, which could expedite their products’ time to market by simplifying the process of meeting cybersecurity regulatory compliance with the FDA and other global agencies.
Medcrypt CEO Mike Kijewski said: “With the increasing need to connect mission-critical medical devices to the internet and directly to each other, having access to an existing, previously certified secure connectivity solution is a game changer.
“Thirdwayv’s decade-long track record of providing comprehensive software and intellectual property solutions for hundreds of millions of smartphone-connected insulin pumps is truly impressive. We look forward to working with Thirdwayv to offer our customers an end-to-end compliant security solution.”
In 2023, MedCrypt collaborated with Stratigos Security to deliver security assessments and penetration testing, expanding its range of third-party assessment and advisory services.
