ISO 13485 (Clause 7.5) - Servicing Protocol

Maintain regulatory compliance and ensure the optimal performance of your medical devices with our ISO 13485:2016 Clause 7.5 Medical Device Servicing Protocol Template. This essential template provides a structured and standardized approach to planning, documenting, and performing servicing activities for medical devices. By following this protocol, your organization can ensure that all servicing activities meet ISO 13485:2016 requirements, improving device safety, performance, and reliability.

✔ Pre-Formatted Servicing Protocol – Fully aligned with ISO 13485:2016 Clause 7.5 requirements for servicing medical devices.
✔ Servicing Requirements & Procedures – Clearly document service tasks, frequency, and responsible personnel for each medical device.
✔ Maintenance & Calibration Procedures – Define maintenance, testing, and calibration protocols to ensure device accuracy and safety.
✔ Risk Management & Safety Considerations – Implement risk assessments to identify potential hazards and ensure compliance with safety regulations.
✔ Traceability & Documentation – Track service history, including dates, tasks performed, and personnel involved in the servicing process.
✔ Audit-Ready Records – Maintain structured records for internal audits and regulatory inspections.
✔ Editable Digital Format – Fully customizable for various medical device types and service needs.

This servicing protocol template is ideal for quality managers, service teams, and compliance officers, ensuring a compliant and systematic servicing approach.

Download the ISO 13485:2016 Medical Device Servicing Protocol Template today to optimize your device servicing and regulatory compliance!