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Iso Leso Application Form New DOC

Iso Leso Application Form New DOC

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how can you apply ISO 1345 Clause 6.4.2 to software not are you required to but how can you we already apply EST controls for electromedical devices to prevent sensitive electrical components from getting damag so what did we do for software the FDA requires that companies provide a plan for malware-free delivery of software so how are you going to create an environment that will be malware free that's one way in IEC 62304 there's a configuration management requirement and as part of configuration management you would isolate the workspaces for each developer so they don't contaminate each other's environment with coding bugs or other problems such as malware two other standards you might consider are IEC 81001 5-1 and ISO IEC 27001

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