ISO 13485 (Clause 7.5) - Requirements for Software Servicing Activities Procedure

Ensure effective software servicing and regulatory compliance with our ISO 13485:2016 Clause 7.5 Requirements for Software Servicing Activities Procedure Template. Proper servicing of software systems within medical devices is essential to maintain performance, safety, and regulatory standards. This ready-to-use template provides a structured procedure for planning, documenting, and executing software maintenance, updates, and corrective actions, ensuring that your organization meets ISO 13485:2016 requirements while safeguarding product quality and patient safety.

✔ Pre-Formatted Software Servicing Procedure – Fully aligned with ISO 13485:2016 Clause 7.5 for software servicing activities.
✔ Servicing & Maintenance Planning – Outline requirements for software servicing, including maintenance schedules, version updates, and bug fixes.
✔ Verification & Validation Guidelines – Define software testing, verification, and validation procedures to ensure the system meets performance criteria.
✔ Risk Management Integration – Assess and manage software risks during servicing and implement appropriate corrective actions.
✔ Audit-Ready Documentation – Maintain structured records for software servicing, including testing, changes, and personnel involved.
✔ Compliance with Regulatory Standards – Ensure that software servicing complies with regulatory requirements and industry best practices.
✔ Editable Digital Format – Customizable for various software systems and service activities.

This software servicing procedure template is ideal for software engineers, quality managers, and regulatory teams, ensuring a compliant, efficient approach to managing software servicing.

Download the ISO 13485:2016 Software Servicing Activities Procedure Template today to optimize your software servicing and compliance processes!