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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
Publication date
2021-06
End date of the objection deadline
2021-08-31
Publisher
Engl. VDI-Gesellschaft Technologies of Life Sciences
Related manuals
Number of pages
27
Available in
German
Abstract

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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