FDA warns of cybersecurity risk in certain medical device software components

[Image from Pixabay]

Kathryn Burke, Emergo by UL

The U.S. Food and Drug Administration (FDA) has issued a cybersecurity alert to medical device manufacturers regarding vulnerabilities that have been identified in the Axeda agent and Axeda Desktop Server.

The FDA alert noted that all versions of Axeda agent and Axeda Desktop Server are affected. The agent and desktop server are owned and supported by computer software company PTC and are used in a number of medical devices across several medical device manufacturers.

Get the full story here at the Emergo by UL’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

 

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European IVDR application partially postponed

Ronald Boumans, Emergo by UL

The European Commission has proposed delaying compliance deadlines for the In-vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), which would allow some manufacturers more time to prepare for compliance to the new Regulation and secure Notified Body support.

Get the full story here at the Emergo Group’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

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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.

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