ISO 13485 (Clause 7.3) - Software Development Procedure (Agile) Template
ISO 13485 (Clause 7.3) - Software Development Procedure (Agile) Template
Template Overview
Template Overview
Developing medical device software requires a structured yet flexible approach to meet ISO 13485:2016 Clause 7.3 – Design & Development requirements while maintaining agility. Our Agile Software Development Procedure Template provides a compliant framework for integrating Agile methodologies into your medical device software development lifecycle (SDLC) while ensuring regulatory adherence.
Key Features
Key Features
✔ Pre-Formatted Agile Software Development Procedure – Covers key ISO 13485:2016 Clause 7.3 requirements.
✔ Agile Development Workflow – Define sprint planning, backlog management, and iteration cycles.
✔ Design & Development Planning Section – Align Agile methodologies with regulatory expectations.
✔ Risk Management & Design Controls – Integrate with ISO 14971 risk management for medical device software.
✔ Traceability & Documentation Requirements – Ensure compliance with design history files (DHF) and software configuration management.
✔ Verification & Validation Process – Define testing, review, and approval workflows within Agile iterations.
✔ Editable Digital Format – Fully customizable for different software classes and regulatory requirements.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for software development teams, regulatory professionals, and quality managers, ensuring compliant, efficient, and iterative medical device software development.
Download the ISO 13485:2016 Agile Software Development Procedure Template today and streamline your regulatory-compliant software development process!
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.