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VDI-MT 5702 Blatt 2 - Draft Medical device software - Medical SPICE - Qualification of developers and assessors

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German title
Medizinprodukte-Software - Medical SPICE - Qualifizierung von Entwickelnden und Assessoren
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Engl. VDI-Gesellschaft Technologies of Life Sciences
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Medical SPICE describes a process assessment model that is used to evaluate the performance of software development for medical products. In the assessment, the standard VDI 5702 Part 1 differentiates between the ability to execute a process and the maturity for an organization or for the interaction of several processes. In assessments, processes can be classified into different maturity levels and weaknesses in process design can be identified. As a result, medical device manufacturers can, among other things, achieve greater security in their collaboration with software suppliers. The experts who perform such assessments according to high quality standards must be qualified and competent. The standard VDI-MT 5702 Part 2 defines the framework and criteria of the assessor qualification.

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