ISO 13485 (Clause 7.3) - Software Development Procedure (Waterfall) Template
ISO 13485 (Clause 7.3) - Software Development Procedure (Waterfall) Template
Template Overview
Template Overview
Medical device software development requires a structured and regulatory-compliant approach to meet ISO 13485:2016 Clause 7.3 – Design & Development requirements. Our Waterfall Software Development Procedure Template provides a clear, step-by-step framework for implementing the Waterfall methodology while ensuring compliance with ISO 13485 and IEC 62304 standards for medical device software.
Key Features
Key Features
✔ Pre-Formatted Waterfall Development Procedure – Aligned with ISO 13485:2016 Clause 7.3 and IEC 62304 requirements.
✔ Stage-by-Stage Development Process – Clearly defined requirements, design, implementation, verification, validation, and release phases.
✔ Design & Development Planning Section – Ensure structured project execution with predefined milestones.
✔ Risk Management & Design Controls – Integrate ISO 14971 risk management for medical device software safety.
✔ Verification & Validation (V&V) Process – Define testing protocols, traceability matrices, and review requirements.
✔ Documentation & Traceability Requirements – Maintain a compliant design history file (DHF) and software configuration management.
✔ Editable Digital Format – Fully customizable for various software classifications and regulatory frameworks.
Why choose a QMS Template?
Why choose a QMS Template?
This ready-to-use template is ideal for software engineers, quality teams, and regulatory professionals, ensuring a fully compliant, structured, and risk-managed software development process.
Download the ISO 13485:2016 Waterfall Software Development Procedure Template today and ensure regulatory-ready software development!
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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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