Product Specification
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
- Specification
- Format
- DOCX
- Language
- English
- Tags
- ISO 13485, Medical Devices, Specification
A Product Specification template that defines the requirements and acceptance criteria for a finished medical device, including identification, models and dimensions, materials and components, performance, biological and chemical safety, sterility, packaging and labelling requirements. It is a design output and forms part of the device master record, and comes with a completed worked example.
What's Inside
- Product Identification
- Models and Dimensions
- Materials and Components
- Performance Requirements
- Biological and Chemical Safety
- Sterility, Packaging and Shelf Life
- Labelling and UDI
- Acceptance Criteria and Release
ISO 13485 Alignment
Supports ISO 13485:2016 requirements, including Clauses 4.2.3, 7.3.3, 7.3.4 and 8.2.6. 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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