Risk Management Procedure
The ISO 14971:2019 compliant 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.
- ISO 14971:2019 Compliant
- FDA QSR Compliant
- ISO 13485:2016 Compliant
- MDR EU 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
Risk Management ProcedureThe 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 - OverviewThe 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.
Risk Management Procedure - ComplianceThe Risk Management Procedure complies with requirements of ISO 14971:2019, ISO 13485:2016, FDA QSR, and MDR EU 2017/745.
For more information about our ISO 14971 Risk Management Procedure contact us at info@aplyon.com
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