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Tag: medical-devices

Tag: "medical-devices"

🛡️ Introducing Advanced Cybersecurity Risk Management on Jira Cloud

...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...

666 views 0 33 Marion Lepmets _SoftComply_ October 24, 2024
- App Central
- Article
- cybersecurity
- fda
- information-security
- medical-device
- medical-devices
- +10 more tags...
Post-Market Surveillance and Risk Management

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...

333 views 0 3 Marion Lepmets _SoftComply_ October 10, 2024
- App Central
- Article
- medical-device
- medical-devices
- risk-management
- softcomply
Hazard Analysis and FMEA: the most common approaches to Risk Management for Medical Devices

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...

1,788 views 0 10 Marion Lepmets _SoftComply_ March 22, 2024
- App Central
- Article
- compliance
- medical-devices
- risk-management
- softcomply