ISO 13485
Design Input 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 defines and documents the design and development inputs for the device. ISO 13485:2016 clause 7.3.3 requires inputs relating to product requirements to be determined and records maintained.
What's Inside
- Input Summary
- User Needs
- Design Input Requirements
- Functional, Performance and Usability
- Safety and Biological Requirements
- Regulatory Requirements and Standards
- Outputs of Risk Management
- Previous Similar Designs
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clause 7.3.3. 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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