SMART quality & compliance
Classification of Software as a Medical device under Medical Device Regulation (European Union)
Classification of software as a Medical device under Medical Device Regulation (European Union) The first step is to determine whether your software is a Medical Device. How do you determine if the software is a Medical Device? Figure 1: How to determine if the Software is a Medical Device. Adapted from COCIR Contribution, Decision diagram for the qualification of Software as Medical Device. Copyright 2020, Kvalito Consulting Group. If your Software is a Medical Device or a part of a Medical Device, it has to be classified. How to classify a Software as a Medical Device under MDR? Figure 2: How to classify a software as a Medical Device. Adapted from the Medical Device Regulation of the European Union, Copyright 2020, KVALITO Consulting Group. Rule 11 refers to software as a Medical Device: “Software intended to provide information which is…
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