ISO 13485
Design Output 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 lists the design and development outputs for the device and shows how they meet the design inputs.
What's Inside
- Output Summary
- Design Output List
- Input-to-Output Mapping
- Essential Characteristics for Safe and Proper Use
- Resolution of Open Input Items
- Information for Purchasing, Production and Service
- Design Output Review (DR2 — Design Freeze)
- Output Change Log (after freeze)
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.4. 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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