Risk Management Procedure

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Risk Management Procedure

The Risk Management Procedure defines the process for the management of risks for medical products in their design, manufacture, and use to ensure they are safe and effective for their intended use.

Risk Management Procedure - Overview

The Risk Management Procedure defines departmental responsibilities and required participants for all risk management activities. The procedure includes guidance on risk management flow, risk estimation, risk control and verification, and instruction on the development of: Risk Management Files; Risk Management Plans; and Risk Management Reports.

The Risk Management Procedure also includes instruction on Production / Post-Production activities. The procedure includes multiple forms complete with helpful instruction.