eQMS

Risk Management Overview

Qualcy eQMS offers a straightforward interface for managing risk management processes that align with ISO14971:2019 and other regulatory standards such as FDA, EU MDR, and Health Canada.

Risk Management Plan

• Define the scope of the device and its lifecycle stages.
• Assign responsibilities.
• 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.
• Identifying reasonably foreseeable misuse.

Hazard identification covers various types of hazards such as biological, electrical, mechanical, and software-related, referencing sources like historical data, standards, and clinical reports.

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

Risk Evaluation

Each risk is compared against the acceptability criteria. If a risk is deemed unacceptable, control measures are implemented. Risk control documentation includes:

• Inherently safe design features, such as rounded edges or lower voltage.
• Protective measures like alarms and shields.
• Information for safety, including 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.

Risk Management Report

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.

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