VDI 5702 Blatt 1 - Draft

Medical device software - Medical SPICE - Process assessment model

At a glance

German title

Medizinprodukte-Software - Medical SPICE - Prozessassessmentmodell

Publication date

2025-05

End date of the objection deadline

2025-07-31

Publisher

Engl. VDI-Gesellschaft Technologies of Life Sciences

Related manuals

• VDI manual Medical Technology

Number of pages

176

Available in

German, English

Abstract

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.

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