Medical device software - Medical SPICE Process assessment model
German title
Medizinprodukte-Software - Medical SPICE Prozessassessmentmodell
Publication date
2017-04
Original language
German,
English
Pages
180
Publication date
2017-04
Original language
German,
English
Pages
180
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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. 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.