Medical device software - Medical SPICE - Process assessment model

Draft technical rule

VDI 5702 Blatt 1:2025-05 - Draft

Medical device software - Medical SPICE - Process assessment model

German title
Medizinprodukte-Software - Medical SPICE - Prozessassessmentmodell
Publication date
2025-05
Original language
German, English
Pages
176

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Publication date
2025-05
Original language
German, English
Pages
176

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Short description

The Medical SPICE Process Assessment Model (PAM) described in this standard is applicable when performing assessments of the software process capability of organisations developing software for medical devices. An integral part of conducting an assessment is to use a process assessment model constructed for that purpose, related to a process reference model and in compliance with the requirements defined in ISO/IEC 15504-2 respectively ISO/IEC 33002, ISO/IEC 33003, ISO/IEC 33004 and ISO/IEC 33020. It provides a framework for process assessment and sets out the minimum requirements for performing an assessment in order to ensure consistency and repeatability of the ratings.

Content

ICS

11.040.01, 35.080, 35.240.80
Replacement amendments

This document has been corrected by: VDI 5702 Blatt 1 Berichtigung:2025-07 .

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