Abstract
Abstract The Medical Technology Advisory Committee of the VDI Society develops a guideline for the implementation of digital process chains for patient-specific medical devices. The underlying medical device constitutes the basis for each individualized medical device. It serves as the development framework for manufacturing.
Highlights
As part of digitization, customers are increasingly being involved in designing their desired product
Health workers cooperate with manufacturers to develop innovative, patient-specific medical devices
The requirements for digital process chains of standardized products in medical technology are described in the quality management [1] and software systems [2] standards
Summary
Customers are increasingly being involved in designing their desired product. Customers can configure their chosen vehicle, plan their own kitchen or design an individual T-shirt. Health workers cooperate with manufacturers to develop innovative, patient-specific medical devices. For patient-specific medical devices, healthcare professionals are involved, via online services, in the design of patient matched and custom-made products. The requirements for digital process chains of standardized products in medical technology are described in the quality management [1] and software systems [2] standards. Requirements from the General Data Protection Regulation (GDPR) [3] must be observed. From the point of view of quality management, the development of digital processes must be attached to the development file
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