REGULATORY: Risk Management
QUALITY_SYSTEM
STANDARDS
DESIGN_CONTROL
RISK_MANAGEMENT
SYSTEM_MODELING
REQUIREMENTS
DESIGN_DESCRIPTION
UNIT_TESTS
VERIFICATION
VALIDATION
TRACEABILITY
AUTOMATED_V&V
  • 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.
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