ARMA AI by Regulatory Thinking

By dietmar Schaffarczyk

Mastering Healthtech Complexity, Byte by Powerful Byte

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• How to plan software validation activities?
• Describe the certification steps for a healthtech device.
• Summarize a chapter from MDR (EU) 2017/745
• What are the differences of ISO 13485:23016 and FDA 21CFR820?

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