Risk Management

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 Analysis based on Intended Use & Characteristics to:

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.

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