Our presentation on Medicine X on Standford University about the 'Unmentionables'; diseases and conditions nobody wants to talk about.

1. Reinventing healthcare through mobile
The Unmentionables

3. Reinventing healthcare through mobile

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11. Manual
Data Information Knowledge
input

12. voidingdiary

13. voidingdiary

14. 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

20. 3D modelling
Surgery planning
Doctor-patient
communication

21. ?
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Event A Event B Event C Event D

22. Reinventing healthcare through mobile
Erik van der Zijden BSc MBA Dr Erich Taubert
@erikdigiredo @thetaub
erik@synappz.nl taub@me.com