WHAT TO INCLUDE IN YOUR TECHNICAL
1. Cover Page (Company, Product/Product Group, Document ID)
2. Index
3. EC declaration of conformity and classification.
4. Name and address of the Manufacturer/European Representative and Manufacturing Plants
5. Product description including:
All variants
Intended clinical use
Indications / contraindications
Operating instructions / warnings / precautions
Photographs highlighting the product, photographs highlighting the usage
Brochures, advertising, catalogue sheets, marketing claims
6. Product specification including:
Parts list
Drawings, assembly drawings
Sub-assembly drawings
Drawings of components
Specifications of materials used including data sheets
List of standards applied
Manufacturing specifications
Sterilisation specifications (if required)
Packaging specifications
QA specifications (QC specs., in-process controls etc.)
Labelling
Accompanying documents
Package insert
Instructions for Use
Service Manual
7. Product verification including:
Testing data and reports
Functionality studies
Wet lab or bench top testing
Materials certificates / reports on biological tests
EMC testing and certificates
Validation of the packaging / ageing studies
Compatibility studies (connection to other devices)
Risk analysis (ISO 14971)
List of requirements (Annex 1) indicating cross-reference with documentation
Clinical Data
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