VDI 5705 Blatt 1:2022-11

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. The standard is also addressed to developers and manufacturers of data generating and recording systems; developers and manufacturers of medical devices, in particular implants, exoprostheses, stents; software and IT developers in medical technology; users of medical devices.

11.040.01, 35.240.80