Modelling in a regulatory centric domain | Stille AB | Capella Days 2020
Channel: Eclipse Capella - Open Source MBSE Solution
Date: 09/11/2020

Modeling in a regulatory centric domain

By John Andersson (Stille AB)

The medical device domain is heavily driven by regulatory requirements and processes that many feel very old fashion. The aim of these notifying bodies is to ensure safety for the patient, user, and environment. Even though the concept of MBSE is widely accepted when it comes to the execution of a project it still often waterfall and V-model methodology.

For long medical device development has been documenting focused domain and we with it. Now we exploring to move into a modeling-centric way of developing our products, and it’s not only technical issues but processes, readability, accessibility, and teamwork that we need to adjust.

Access to all of the Capella Days 2020 slides: https://fr.slideshare.net/Obeo_corp/clipboards/capella-days-2020

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