Medical Device Risk Management Procedure
$149.00
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The medical device risk management procedure defines the process for the management of risks for medical products in their design, manufacture, and use to ensure the medical devices are safe and effective for their intended use. Risk planning, analysis, evaluation, control, and post-production activities are defined. Minimum participants for various risk analysis tasks are identified. Creation of a risk management file, report, and review instructions are included. The procedure complies with ISO 14971:2019, ISO 13485, and FDA QSR. Medical device risk management procedure includes related forms.
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