Design Risk Management Procedure
SKU: SOP 7-030
The ISO 14971 Design Risk Management Procedure focuses on design elements of the risk management process. The design risk management procedure is aligned with the requirements of ISO 14971:2012.
- ISO 14971:2012 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MDR (EU) 2017/745 Compliant
- Includes Related Forms
- MS Word and Excel Format
- Digital Content - Instant Download
ISO 14971 Design Risk Management Procedure
The ISO 14971 Design Risk Management Procedure defines the process for conducting design risk analysis for risks associated with medical products. This procedure is made part of the overall risk management process. The ISO 14971 design risk management procedure includes excel spreadsheets and related forms designed to capture and help design teams to identify, estimate, control, and re-estimate risks after implementing risk control measures.
ISO 14971 Design Risk Management Procedure Overview
Design Risk Management process should be conducted at the product system level. If this is not feasible, then the process may be applied to a single product. The Design Risk Management should be initiated prior to or in parallel with product specification development and development of a products functional requirements.
Design Risk Hazard Identification
Identify all known or foreseeable hazards. Complete FORM 0005. Possible input sources to consider include:
o Product specifications
o Foreseeable hazards, including misuse
o Risk management files of similar devices
o Clinical evidence
o Published data
o Scientific data
o Complaint Data
o Applicable standards.
o ISO 14971:2012, Appendix C.2 Questions
o Safety and Performance Requirements according to Annex I, MDR 2017/745
o Review of clinical procedures
Design Risk Estimation
Estimate the risk for each hazardous situation.
Design Preliminary Risk Level
Enter the risk level determined by the combination of the severity of harm and the probability of occurrence of harm using the Product Risk Acceptance Matrix.
Design Risk Control Measures
Design Risk control measures can reduce the “severity of harm” or reduce the “probability of occurrence of harm” or both.
Review of Design Risk for Design Changes
In the event of a design change, a review of the Risk Management File is mandatory. If no update of the Risk Management File is necessary, the decision to not update the Risk Management File has to be documented
Review of Design Risk Management during Post Market Surveillance
If market feedback is available for the product such as customer feedback, product complaints, product related CAPA’s, etc., the risk analysis should be reviewed to determine if there are any risks not previously identified or if the severity or probability of occurrence of harm remain valid.
ISO 14971 Design Risk Management Procedure Compliance
The ISO 14971 Design Risk Management Procedure complies with requirements of ISO 14971:2012. The Design Risk Management Procedure is also FDA QSR and ISO 13485:2016 compliant.
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