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Technical rule [CURRENT]

VDI-MT 5702 Blatt 2:2023-03

Medical device software - Medical SPICE - Qualification of developers and assessors

German title
Medizinprodukte-Software - Medical SPICE - Qualifizierung von Entwickelnden und Assessoren
Publication date
2023-03
Original language
German, English
Pages
50

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Publication date
2023-03
Original language
German, English
Pages
50

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Short description
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 shall be qualified and competent. Therefore, this standard defines the framework and criteria of the assessor qualification.
Content
ICS
03.100.30, 35.240.80
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