Technical writing

1. Letter of attorney

2. QMS Certificates:

 2.1.QMS Certificate with requirements of EN ISO 9001

 2.2. QMS Certificate with requirements of EN ISO 13485

3. MD Technical File

 3.1. Name and address of manufacturer

 3.2. Product description

 3.3. MD Classification

 3.4. Product specification

 3.5. Specification of raw materials and components

 3.6. Labeling (Primary and secondary packaing)

 3.7. List of applied standards

 3.8. Risk analysis report

 3.9. Essential requirements checklist

 3.10. Development documents (test reports, drawing, calculations, diagrams, design specification):

 3.10.1. Sterilization validation test

 3.10.2. Materials data sheet

 3.10.3. Physical and chemical studies

 3.10.4. Biocompatibility test

 3.11. Manufacturing process

 3.11.1. Manufacturing process description

 3.11.2. Production process flow

 3.12. Evidence of stability (storage life, stability during transport, use-stability)

          Shelf life study protocols

          Accelerated aging study

 3.12.1. Climate simulation

            Transport simulation

            Chemical analysis

 3.12.2. Other studies protocols

 3.13.Evidence of the compliance with the essensial requirements if the product is combined with other medical devices as intended

 3.14. Sterilization process description

 3.15. Packaging process description and validation

 3.16. Other process validation

 3.17. Evidence of the compliance of the measurement precision (if applicable)

 3.18. Information regarding other registrations

 3.19. EC Declarations of Conformity

 3.20. Certificates and decisions of notified bodies

 3.20.1. Full Quality Assurance System EC Certificate

 3.20.2. EC Design Examination Certificate

 3.21. Documentation of changes

4. Instruction for use

5. Pre-clinical evaluation report

6. Clinical evaluation report

7. Post-marketing clinical safety study of MD

8. Quality Manual