44. 1.1 Product
1.2 Manufacturer
1.3 Contact Information Manufacturer
1.4 Subcontractors Software Development
1.5 Conformity Assessment Route
1.6 Regulatory status
2. Device Description
3. Classification
4. Intended Use
5. Conformity Assessment Procedure
6. Declaration of Conformity
7. Comparison to Equivalent CE Marked Devices
8. Essential Requirements
9. Summary of Design Development
9.1Functional design Requirements
9.2 Software Development Process
9.3 Version Control and traceability
9.4 Cycle Dataset
9.5 Software Testing
9.6 Design verification and validation
10. Manufacturing
11. Packaging and Sterilization
12. Quality System
13. Risk Management and Analysis
14. Suppliers and Subcontractors
15. Labeling
15.1 Product Labeling
15.2 Instructions for Use
15.3 Warnings and precautions
15.4 Marketing Brochure
15. References
Appendix 1 Functional Design for iP Voiding Diary
Appendix 2 Cycle Dataset iP Voiding Diary
Appendix 3 Classification of iP Voiding Diary as Medical Device
Appendix 5 User Guide iP Voiding Diary
Appendix 6 Apple Review Guidelines
Appendix 7 Software development iP Voiding Diary
Appendix 8 Marketing Brochure iP Voiding Diary
Appendix 9 Instructions for Use
Appendix 10 Declaration of Conformity
Appendix 11 Functional Design for iP Voiding Diary
Appendix 12 Graphical Design
59. Erik van der Zijden Piet Nelis Erich Taubert
Jessica Seegers Dick Coppus Mindy Broeren Jolanda Hutten
Lead Designer Lead Designer Office Manager & Editor Visual Designer
Eduard Ernst Sami Yilmaz Frans Kouwenhoven René van den Bos DVM
Content Creation Mobile Development Mobile Development Cofounder DigiRedo
?
Rob van der Galiën Sebastiaan Seegers Taha Chebli
Web developer Game developer Motion Graphic Designer You?
60. Records your drinks, pees and urine loss.
Includes urge and pain scores.
Shows your results in clear infographics.
Compares your data to literature standards.
Sends your PDF-report by email.
ipvoidingdiary
ip-voiding-diary.com
erik@synappz.nl