Qualcy eQMS provides simple interface for managing Risk Management process that complies with ISO14971:2019 and other regulatory bodies (FDA, EU MDR, Health Canada).
- Risk Management Plan to:
- Define scope of the device and lifecycle stages covered.
- Assign responsibilities.
- Define risk acceptability criteria (per device class/region).
Risk Analysis based on Intended Use & Characteristics to:
- Clearly define intended use and indications.
- Identify reasonably foreseeable misuse.
Hazard Identification for different types of hazards (Biological, electrical, mechanical, software-related, etc.), reference to sources like historical data, standards, clinical reports.
Risk Estimation based on: Probability of occurrence (of harm) and Severity of harm.
Format: Risk = Probability × Severity
Risk Evaluation includes:
Compare each risk against acceptability criteria, If unacceptable, proceed with control measures.
Risk Control documentation for Inherently safe design (e.g., rounded edges, lower voltage), Protective measures (e.g., alarms, shields), Information for safety (e.g., labeling, instructions).
Evaluation of Overall Residual Risk to Evaluate combined residual risks, Conduct a benefit-risk analysis if risks remain high which may require stakeholder input or clinical evidence.
- Risk Management Report provides summary of:
- All risk activities.
- Justification for acceptability of residual risks.
- Confirmation that the risk management process was followed.