Document Type : Viewpoint
Authors
1 Research Group of Biostatistics and Medical Informatics (BISI), Department of Public Health (GEWE), Vrije Universiteit Brussel, Brussel, Belgium
2 Research Group Clinical Pharmacology and Clinical Pharmacy (KFAR), Centre for Pharmaceutical Research (CePhar), Vrije Universiteit Brussel, Brussel, Belgium
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Keywords
Introduction
Use of of Software as a Medical Device (SaMD) is continuously increasing. SaMD is defined by the International Medical Device Regulators Forum (IMDRF) as software intended to be used for medical purposes without being part of a hardware medical device.1 SaMD is software that can perform complex clinical tasks such as diagnosing medical conditions, suggesting treatments and informing clinical management.1...(Read more...)