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Technical Specifications of Medical Devices

Technical Specifications of Medical Devices. Mohammad Ameel Senior Consultant, Healthcare Technologies (Medical Devices) Collaborator, International Federation of Medical and Biological Engineering WHO Collaborating Centre for Priority Medical Devices & health Technology Policy

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Technical Specifications of Medical Devices

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  1. Technical Specifications of Medical Devices Mohammad Ameel Senior Consultant, Healthcare Technologies (Medical Devices) Collaborator, International Federation of Medical and Biological Engineering WHO Collaborating Centre for Priority Medical Devices & health Technology Policy National Health Systems Resource Centre Ministry of Health & Family Welfare, Government of India Fourth WHO Global Forum on Medical Devices

  2. Disclosure/Announcements The presenters declare no conflict of interest with the materials provided Acknowledgement/Reference : USER GUIDE: WHO technical specification for medical devices Furthermore, we do not claim the following statements: 1. These technical specifications are exhaustive or error free 2. the technologies which are included will be embodied in future editions of technical specifications 3. the use of the technologies listed is, or will be, in accordance with the national laws and regulations of any country Fourth WHO Global Forum on Medical Devices

  3. Disclaimer • Technical specifications should be tailored appropriately by users according to the specific situation • Technical characteristics of technical specifications are generic in nature • The number of accessories, consumables, spare parts and other components indicates usual and/or ideal number and is not a mandatory quantity. • For tender purposes, you should consider not only medical equipment itself, but also related services in order to be able to use the equipment. Fourth WHO Global Forum on Medical Devices

  4. Usability analysis for technical specifications Fourth WHO Global Forum on Medical Devices

  5. Methodology

  6. The Template

  7. Other service to be considered • Delivery at Place • Preliminary Acceptance • Installation • Supplier testing and commissioning • Training to the maintenance personnel • Training to the equipment users • Provisional Equipment handing over • Manufacturer Warranty • Supplier/installer additional Warranty • Final Taking over certificate • After Warranty service Fourth WHO Global Forum on Medical Devices

  8. Progress So far… Fourth WHO Global Forum on Medical Devices

  9. Specifications under review… Fourth WHO Global Forum on Medical Devices

  10. Thank you Fourth WHO Global Forum on Medical Devices

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