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The Unmentionables

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

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The Unmentionables

  1. 1. Reinventing healthcare through mobile The Unmentionables
  2. 2. Reinventing healthcare through mobile
  3. 3. ?
  4. 4. Manual Data Information Knowledge input
  5. 5. voidingdiary
  6. 6. voidingdiary
  7. 7. 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
  8. 8. 3D modelling Surgery planning Doctor-patient communication
  9. 9. ? 000 00 1 101 010 00 01 1 010 101 00 01 100 101 100 0 11 01 10 010 101 101 00 01 11 011 10 100 01 010 1 110 10 010 00 001 10 01 011 010 10 101 0 110 10 1 10 010 100 01 101 010 10 0 010 01 1 1 001 10 01 0 10 Event A Event B Event C Event D
  10. 10. Reinventing healthcare through mobile Erik van der Zijden BSc MBA Dr Erich Taubert @erikdigiredo @thetaub erik@synappz.nl taub@me.com

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

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