Risk Management

The Risk Management system by Qualcy eQMS offers a straightforward interface for handling risk management processes in alignment with ISO14971:2019 and other regulatory standards such as FDA, EU MDR, and Health Canada.

The system facilitates the creation of a Risk Management Plan to define the scope of the device and its lifecycle stages, assign responsibilities, and establish risk acceptability criteria based on device class and region.

Risk Analysis

Risk analysis is conducted based on the intended use and characteristics of the device. This includes clearly defining the intended use and indications, as well as identifying reasonably foreseeable misuse.

Hazard identification is performed for various hazard types, including biological, electrical, mechanical, and software-related hazards, with references to sources like historical data, standards, and clinical reports.

Risk estimation is calculated based on the probability of occurrence of harm and the severity of harm, using the format: Risk = Probability × Severity.

Risk Evaluation

Each risk is compared against acceptability criteria. If a risk is deemed unacceptable, control measures are implemented. Documentation of risk control includes inherently safe design features, protective measures, and safety information such as labeling and instructions.

The evaluation of overall residual risk involves assessing combined residual risks and conducting a benefit-risk analysis if high risks persist, potentially requiring stakeholder input or clinical evidence.

The Risk Management Report provides a summary of all risk activities, justifications for the acceptability of residual risks, and confirmation that the risk management process was adhered to.

For further engagement, users are encouraged to contact for a demo or a 30-day free trial, with a commitment to customer satisfaction.