Design Verification Record
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
- Standard
- ISO 13485
- Document Type
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record documents a design verification activity: the plan, the test, the results and the conclusion. ISO 13485:2016 clause 7.3.6 requires design and development verification to be performed in accordance with planned and documented arrangements to ensure that design outputs have met design input requirements.
What's Inside
- Part A — Verification Identification
- Part B — Verification Plan
- Part C — Equipment and Materials
- Part D — Test Conditions
- Part E — Results: Run 1 (DRW-1003 rev. A)
- Part F — Investigation and Design Change
- Part G — Results: Run 2 (DRW-1003 rev. B)
- Part H — Conclusion
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.6. 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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