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F. Burgers

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A Strategy for the Certification of a Medical Device for the Kenyan Market

The development of the Chloe Syringe Extension Device (SED) is an initiative of Karlheinz Samenjo, Dr Gwer and Dr Aparna for the Kenyan market. The Chloe SED is a reusable, 3D-printable device that extends the locally available 10ml syringes and it is designed for female patients to be used for procedures related to pregnancy issues, such as Manual Vacuum Aspiration (MVA). The embodiment design is nearing completion. This master thesis explores further steps on the Chloe SEDs route to the introduction in Kenya, both legal and non-legal. Ultimately, this research aims at providing recommendations that can contribute to the acceptance of the device by its users.
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