ISO 13485 (Clause 7.1) - Risk Identification Analysis & Control (General)

Ensure effective risk management and regulatory compliance with our ISO 13485:2016 Clause 7.1 Risk Analysis (General) Template. Risk analysis is a critical component of maintaining the safety and performance of medical devices throughout their lifecycle. This ready-to-use template provides a comprehensive framework for conducting risk assessments, identifying potential hazards, and evaluating their impact in alignment with ISO 13485:2016 requirements. It helps your organization proactively manage risks to ensure product quality and patient safety.

✔ Pre-Formatted Risk Analysis Template – Fully aligned with ISO 13485:2016 Clause 7.1 for conducting general risk assessments.
✔ Risk Identification – Define potential hazards associated with the medical device and its associated processes.
✔ Risk Evaluation & Impact Assessment – Evaluate severity, probability, and risk acceptability based on established criteria.
✔ Risk Control Measures – Develop and document actions to mitigate risks and ensure safety.
✔ Residual Risk Documentation – Identify and assess residual risks after controls are implemented.
✔ Audit-Ready Documentation – Maintain organized, traceable records for internal audits and regulatory inspections.
✔ Editable Digital Format – Customizable for various devices, risks, and risk management processes.

This Risk Analysis Template is ideal for quality managers, risk management teams, and compliance officers, ensuring a proactive, compliant risk management approach.

Download the ISO 13485:2016 Risk Analysis (General) Template today and strengthen your risk management processes!