ISO 13485
Design Change Record
Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.
Fully Customizable
Audit Ready
Instant Download
- Standard
- ISO 13485
- Document Type
- Records
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Records
This record controls a change to the design of a medical device during development or after release.
What's Inside
- Part A — Change Request
- Part B — Significance Assessment
- Part C — Impact Evaluation
- Regulatory Assessment
- Part D — Verification and Validation
- Part E — Approval for Implementation
- Part F — Implementation
- Part G — Effectiveness Check and Closure
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.9. 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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