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VDI 5703

Systematical development for a model-based testing of medical devices

active, Most Current
Organization: VDI
Publication Date: 1 September 2015
Status: active
Page Count: 34
ICS Code (Medicaments): 11.120.10
ICS Code (Medical equipment in general): 11.040.01
ICS Code (Medical science): 11.020.20
scope:

The scope of this VDI Standard is meant for the development of model-based tests (e.g. on the basis of physical, chemical, biological, or numeric models), which are applied in order to ensure warranty of safety and function, product design and development, certification, reimbursement by public health insurances or product monitoring of medical products,

• for materials, components, or complete products,

• by manufacturers and users of medical devices, research institutions, test institutes and other authorities.

This standard does not cover:

• empirical studies on human beings (clinical studies)

• software

• combination products in conjunction with pharmaceuticals or cells (ATMPs)

Document History

VDI 5703
September 1, 2015
Systematical development for a model-based testing of medical devices
The scope of this VDI Standard is meant for the development of model-based tests (e.g. on the basis of physical, chemical, biological, or numeric models), which are applied in order to ensure...

References

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