ISO 13485
Design Validation Record
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
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- Standard
- ISO 13485
- Document Type
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents design validation — confirmation that the device meets the requirements for its specified application or intended use.
What's Inside
- Validation Identification and Product Used
- User Needs and Validation Activities
- VAL-01 — Simulated Use
- VAL-02 — Summative Usability Evaluation (IEC 62366-1)
- Analysis of Use Errors and Close Calls
- Supplementary Validation after DCR-1003-02
- VAL-03 — Clinical Evaluation
- Labelling and IFU Validation
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.7. It fits with the rest of the QEHS Vault ISO 13485 document set.
Format
Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.
Key Benefits
- Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements
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