The Unmentionables

Reinventing healthcare through mobile

Reinventing healthcare through mobile

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Manual input Information KnowledgeData

voidingdiary

voidingdiary

1.1 Product 1.2 Manufacturer 1.3 Contact Information Manufacturer 1.4 Subcontractors Software Development 1.5 Conformity Assessment Route 1.6 Regulatory status2. Device Description3. Classification4. Intended Use5. Conformity Assessment Procedure6. Declaration of Conformity7. Comparison to Equivalent CE Marked Devices8. Essential Requirements9. 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 validation10. Manufacturing11. Packaging and Sterilization 12. Quality System13. Risk Management and Analysis14. Suppliers and Subcontractors15. Labeling 15.1 Product Labeling 15.2 Instructions for Use 15.3 Warnings and precautions 15.4 Marketing Brochure15. References

Appendix 1 Functional Design for iP Voiding DiaryAppendix 2 Cycle Dataset iP Voiding DiaryAppendix 3 Classification of iP Voiding Diary as Medical DeviceAppendix 5 User Guide iP Voiding DiaryAppendix 6 Apple Review GuidelinesAppendix 7 Software development iP Voiding DiaryAppendix 8 Marketing Brochure iP Voiding DiaryAppendix 9 Instructions for UseAppendix 10 Declaration of ConformityAppendix 11 Functional Design for iP Voiding DiaryAppendix 12 Graphical Design

3D modelling

Surgery planning

Doctor-patient communication

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Erik van der Zijden BSc MBA

@erikdigiredoerik@synappz.nl

Dr Erich Taubert

@thetaubtaub@me.com

Reinventing healthcare through mobile