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- Tag: medical-devices
Tag: "medical-devices"
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Medical device companies face a constant challenge: how do you validate cloud software tools that update daily? If you’re using Confluence Cloud for your quality management system, you need validatio...
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Risk management in the medical device industry isn’t optional – it’s literally life or death. If you’re developing medical devices, you need to identify, assess, and mitigate risks throughout your en...
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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...
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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...
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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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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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