Tag: "medical-devices"

In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact pati...

• App Central
• fmea
• hazard-analysis
• medical-devices
• risk-management
• risk-manager
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...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...

• App Central
• cybersecurity
• fda
• information-security
• medical-device
• medical-devices
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...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.

• App Central
• medical-device
• medical-devices
• 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...

• App Central
• compliance
• medical-devices
• risk-management
• softcomply