ISO 13485 (Clause 7.1) - Medical Device File (Technical File) Risk Management Procedure Template

Ensure that all medical device files are properly managed with a strong focus on risk management using our ISO 13485:2016 Clause 7.1 Medical Device File Risk Management Procedure Template. Effective risk management is essential for ensuring the safety and regulatory compliance of your medical devices throughout their lifecycle. This ready-to-use template provides a structured approach to assessing, documenting, and controlling risks within your medical device files, ensuring that all aspects of risk analysis, control measures, and mitigation strategies are properly documented in accordance with ISO 13485:2016.

✔ Pre-Formatted Risk Management Procedure – Aligned with ISO 13485:2016 Clause 7.1 for managing risks in medical device files.
✔ Device File Risk Assessment – Identify specific risks related to the device file, including design, manufacturing, and post-market activities.
✔ Risk Evaluation & Control Measures – Evaluate severity, likelihood, and risk impact and define risk control actions to minimize potential issues.
✔ Mitigation and Action Plans – Document corrective actions and preventive measures to reduce risk exposure.
✔ Audit-Ready Documentation – Maintain detailed records for internal audits, regulatory inspections, and compliance verification.
✔ Editable Digital Format – Customizable for various medical devices and company-specific requirements.

This Medical Device File Risk Management Procedure Template is ideal for quality managers, regulatory affairs teams, and compliance officers, ensuring an organized, compliant approach to risk management.

Download the ISO 13485:2016 Medical Device File Risk Management Procedure Template today to strengthen your risk management strategy and regulatory compliance!