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REGULATORY SERVICES: Risk Management
- Syprosoft Engineering has extensive experience with the risk management process and follows the ISO 14971 standard - Application of Risk Management to Medical Devices. In accordance with this standard, we have helped our clients prepare and update their risk analyses by using both production and post-production data, and data from published literature. The table below shows an example of the types of production and post-production data used for the analysis.
- Hazard Category
- Item
- Potential Effect(s) of Failure
- Failure Mode
- Mitigation
- Mitigation Implementation
- Failure Cause
- End Effect
- Risk Code
- Severity
- Occurrence
- Detectability
- Initial Risk
- Mitigated Severity
- Mitigated Occurrence
- Mitigated Detectability
- Severity Rationale
- Occurrence Rationale
- Detectability Rationale
- Final Risk
- Complaint-MDR Qty
- NCR Qty
- % Occurrence
- Devices containing software have additional regulatory requirements based on Level of Concern. The FDA provides guidance on determining the Level of Concern for software.
- Major Level of Concern: The level of concern is Major if a failure or latent flaw in the software could result in the death or serious injury to either the patient or the operator. The level of concern is also Major if a failure or latent flaw in the software could indirectly result in death or serious injury of the patient or operator through incorrect or delayed information or through the action of a care provider.
- Moderate Level of Concern: The level of concern is Moderate if a failure or latent design flaw in the software could directly result in minor injury to the patient or operator. The level of concern is also Moderate if a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
- Minor Level of Concern: The level of concern is Minor if failures or latent design flaws are unlikely to cause injury to the patient or operator.