Tag: "medical-devices"

...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...

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• cybersecurity
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All product development teams let out a sigh of relief when a product is launched. The hard technical work is done, tight deadlines met (more or less), submissions completed and approved. Time to han...

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• medical-device
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• risk-management
• softcomply

What is Hazard Analysis? Hazard Analysis is described as the Risk Management process in ISO 14971. It is a Top-Down type of risk analysis, starting from the end effects - Hazards and Hazardous Situ...

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• compliance
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