Medical Device Risk Management Report Template
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Medical device risk management report template. The risk management report should be a summary technical document i e sted. However you may have risks specific to a device or a family of devices which may require mitigation actions after design. Risk management plan template medical device and iso 14971 49 00 related products. Tabular report template the rts also provides a good foundation for new risk management requirements such as safety assurance cases.
European union medical device directive 98 79 ec. Medical device risk management 15. 21 cfr 820 preamble 21 cfr 820 30 g design validation. Risk referred to in 24 separate essential requirements.
Risk management regulatory requirements for risk management usa food and drug administration fda. The sted should reference the procedure that was used and indicate all the risk management activities that were performed specifically to the product or product family defined in the scope of the risk management report. Procedures and forms like production delivery capa post market surveillance address risks after design. 7 report risk management activities to the kansas department of health and environment and other appropriate licensing agencies as mandated by law iii governing body authority the governing board duly authorizes the risk management committee and the medical staff executive.
This is classical in risk management but this second part contains an additional section. The estimate suggests the phases of product construction and the time required for their implementation. Status report template full free 0 00 design review record template free 0 00 risk management plan template medical device and iso 14971 49 00 design and development plan template medical device per iso 13485 and 21 cfr 820 49 00 standard operating procedure sop for risk management according to en iso 14971 2019 99. Safety assurance case for medical devices.
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