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Akili: A Novel Approach to Clinical Intervention with Digital Therapeutics
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
As the development of Akili's software continued, the company implemented appropriate controls to align with the established medical device quality and software lifecycle management standards. Specifically, Akili established all the procedures and processes for compliance with 21 CFR 820 and ISO 13485 medical device quality standards10 and produced software in accordance with the IEC 62304 standard11 for medical devices software.
Regulatory Considerations When Deploying your Software in a Clinical Environment
Published in Johan Helmenkamp, Robert Bujila, Gavin Poludniowski, Diagnostic Radiology Physics with MATLAB®, 2020
Philip S. Cosgriff, Johan Åtting
Process standards: EN/IEC 62304:20065. Medical device software—life cycle processesEN/IEC 62366:20076. Medical devices—Application of usability engineering to medical devices
Regulatory convergence of medical devices: a case study using ISO and IEC standards
Published in Expert Review of Medical Devices, 2018
Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki
The IEC is a not-for-profit, quasi-governmental organization, founded in 1906. The IEC members are national committees, and they appoint experts and delegates from industry, government bodies, associations, and academia to participate in the technical and conformity assessment work of the IEC. The IEC has 104 TCs and defines the scope of each TC [23]. In the medical device industry, for example, IEC/TC 62 ‘Electrical equipment in medical practice’) is responsible for electrical equipment used in medical practice and develops many standards such as IEC 60601–1 ‘Medical electrical equipment – Part 1: General requirements for basic safety and essential performance’ and IEC 62304 ‘Medical device software – Software life-cycle processes.’