Collection: ISO 13485 Templates
Implementing ISO 13485:2016 requires comprehensive documentation to meet regulatory standards. Our ISO 13485 templates provide medical device companies with ready-to-use documentation that simplifies compliance. These professionally designed templates include complete manuals, procedures, and forms that address critical requirements like complaint handling, CAPA, and risk management. Save hundreds of hours of development time with our expert-crafted templates that align with global regulatory expectations.
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ISO 13485 (Clause 4.1) - Master Software List Template
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ISO 13485 (Clause 4.1) - Master Software List Template for High Risk Devices
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ISO 13485 (Clause 4.1) - Risk Analysis Template - Software
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ISO 13485 (Clause 4.1) - Software Acceptance Testing
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ISO 13485 (Clause 4.1) - Software Validation Procedure
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ISO 13485 (Clause 4.1) - Software Validation Procedure for High Risk Devices
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ISO 13485 (Clause 4.2) - Change Control Log Template
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ISO 13485 (Clause 4.2) - Control of Records Procedure
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ISO 13485 (Clause 4.2) - Document Control Procedure
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ISO 13485 (Clause 4.2) - Document Review Guidance Template
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ISO 13485 (Clause 4.2) - Master Document List Template
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ISO 13485 (Clause 4.2) - Post Market Surveillance Plan Template
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ISO 13485 (Clause 4.2) - Quality Manual Template
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ISO 13485 (Clause 5.0) - Management Responsibilities Procedure
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ISO 13485 (Clause 5.3) - Quality Policy Template
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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log
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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Procedure
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ISO 13485 (Clause 5.4) - Planned Deviation Request Form
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ISO 13485 (Clause 5.4) - QMS Change Request Form
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ISO 13485 (Clause 5.4) - Quality Management Planning Procedure Template
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ISO 13485 (Clause 5.4) - Quality Objectives & Planning Template
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ISO 13485 (Clause 5.6) - Management Review Meeting Agenda Template
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ISO 13485 (Clause 5.6) - Management Review Meeting Minutes Template
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ISO 13485 (Clause 5.6) - Management Review Meetings Schedule
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Why Choose Our ISO 13485 Templates?
- Comprehensive Coverage – Complete set of templates covering all ISO 13485:2016 documentation requirements.
- Regulatory Compliant – Aligned with FDA, EU MDR, and QSR, and global regulatory standards.
- Customisable & Ready-to-Use – Simply add your company information and implement immediately.
- Expert-Developed – Created by regulatory professionals with decades of medical device experience.
- Regular Updates – Templates updated to reflect the latest regulatory changes and interpretations.
These templates provide structured guidance through complex ISO 13485 requirements including document control, production planning, design controls, and complaint handling processes – ensuring your quality management system is both compliant and efficient.