The EU AI Act is here – the world’s first major AI regulation, reshaping how companies build and use intelligent systems. For medical device software, this means tighter rules, higher expectations, a...
...nformation from suppliers and wholesalers that distribute your product. Information from publicly available published scientific literature. One of the most “recent” aspects is cybersecurity s...
...bsp;our partner Jodocus' blog.
...ust if you are planning to enter the US governative market. The NIST Special Publication (SP) 800 series applies to US federal agencies, organizations and their suppliers/subcontractors when c...
...oftComply blog.
...anage your risks in Jira or book a demo to learn more. 👋 Will you attend Medica? Book a slot to meet our team there: This article was originally published in SoftComply blog.
...emo to learn more about managing information security risks in Jira – https://calendly.com/softcomply/softcomply-risk-manager-demo This article was originally published in SoftComply blog.
In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...
Your medical device software is likely to contain a number of components, items, packages, libraries, etc. not developed directly by your company. It may include open-source or purchased software. Un...
Risk management in the Regulated Industries is often viewed as a necessary evil, but what if we approached it as a secret weapon instead? It's a common misconception that risk management slows down...
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