2. Management system-ISO9001, ISO13485 (if required)
3. Basic information about the company (name, address, European representative office, European sales representative)
4. Intended use, classification (in what environment, precautions, etc.)
5. Solutions in case of failure to meet the basic requirements of the standard (MDD 93/42/EWG, EWG, precautions, etc.)
5. Solutions in case of non-compliance with the basic requirements of the standard (MDD 93/42/EWG, Annex I)
6. Description of the product (indications and contraindications, instructions for use, description of the composition of the medical substance in question, description of the special precautions, accessories and other components), production process.
7. Design drawings, photographs, operating manuals.
8. Catalogs, advertising and sales materials (if any)
9. Information on packaging (warning labels, use of labels, signage, storage, transport and handling)
10. Composition of the product (descriptions of circuits, components, functions; list of parts, pictures; sample drawings of the product)
11. Manufacturing processes and methods (environmental conditions in the process; description of the sterilization process - the process of production)
12. Production process and methods (environmental conditions during production; description of sterilization process, if any)
12. MSDS (Chemical Safety Data Sheet)
13. Description of packaging materials and labels
14. Quality assurance measures (process quality control, sterilization process control)
15. Technical requirements and Labeling
16. Catalog of design requirements (laws and regulations, harmonized standards and other standards used)
17. Test plans, test reports (summary of design results)
18. Product labels and names (sterilization - if applicable)
19. Accompanying documentation (operation manuals, patient information, sterilization process) (operation manual, patient information, proof of meeting European language requirements)
20. Testing section
a. Physical performance testing,
b. Effectiveness testing
c. Medical device coatings, coatings and finishes
d. Medical device coatings, product safety requirements
e. Certificate of conformity for product sterilization
f. Certificate of conformity for product sterilization
f. Certificate of conformity for product sterilization
f.
f. Software
g. Electromagnetic compatibility
h. Safety regulations
21. Stability testing (life span)
22. Confirmation of packaging materials (physical properties, transport packaging, packaging labels, life span testing, maintenance of sterilisation - if required)
23. 23. Evaluation of compatibility of device and other substances (if any)
24. Compatibility of device with other medical devices (if any)
25. Biocompatibility, toxicity testing (10993)
26. Clinical examination/data/evaluation (in vitro testing, etc.)
27. Publications, literature (data collection, comparison)
28. p>28. Design change application if there is a design change in the product
29. 14971 (Hazard Analysis Report/Plan/Evaluation), FMEA, Complaint History, Risk Management using animal organizations according to the law - if any
30. Summary: Benefit/Risk Evaluation