risk management

Article

The MDCG cybersecurity guidance – a helpful rush job

It has been some time since the MDCG guidance on cybersecurity for medical devices was released (MDCG 2019-16 December 2019), so everybody has probably had the opportunity to get used to the document by now. While the document is by no means ideal or even flawless (congratulations MDCG on a glaring spelling mistake in the […]

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Software design for medical devices

I just returned from an interesting conference in Munich about software design for medical devices. I had the privilege to present on legal issues and some regulatory issues related to software and…

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