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VDI 5705 Blatt 1 - Draft Digital process chains in industrial manufacturing for medical devices - Custom-made devices

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German title
Digitale Prozessketten in der industriellen Medizintechnik - Herstellung von Sonderanfertigungen
Publication date
2021-08
End date of the objection deadline
2021-10-31
Publisher
Engl. VDI-Gesellschaft Technologies of Life Sciences
Related manuals
Number of pages
26
Available in
German
Abstract

The standard recommends a systematic and structured process chain for the industrial production of patient-specific medical devices (custom-made devices). The recommendations of this standard do not replace a quality management system. It is particularly aimed at manufacturers of medical devices who plan, develop, produce, and distribute their custom-made devices with the help of a continuous digital workflow. The individual sub-processes build upon each other and are to be transferred in this order to the in-house situation, regardless of whether the recommended process chain is to be applied in whole or in part. For a better understanding of the digital process chain, exemplary process chains of different custom-made devices are shown and exemplified.

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