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Medical device software - Medical SPICE - Process assessment model

Technical rule [NEW]

VDI 5702 Blatt 1:2026-01

Medical device software - Medical SPICE - Process assessment model

German title
Medizinprodukte-Software - Medical SPICE - Prozessassessmentmodell
Publication date
2026-01
Original language
German, English
Pages
179

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Publication date
2026-01
Original language
German, English
Pages
179

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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 replaces VDI 5702 Blatt 1:2017-04 .

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