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Medical Device Manufacturing Risk Assessment

Assessing Risk: 5 Tips for Medical Device Risk Management

What is Risk Management Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike. Risk Management Standards for the Medical Device Industry Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as [...]

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