Day

February 16, 2017
Although IEC 82304-1 Health Software: General requirements for safety has been published it is not clear when it will be harmonized in the EU. Nonetheless it appears EU notified bodies are treating it as “state-of-the-art” and are likely to expect it to be used for software products that are regulated as medical devices. IEC TR...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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