Logiciels de dispositifs médicaux -- Processus du cycle de vie du logiciel
Définit les exigences du cycle de vie des logiciels de dispositifs médicaux. L'ensemble des processus, activités et tâches décrit dans la présente norme constitue un cadre commun pour les processus du cycle de vie des logiciels de dispositifs médicaux.
https://www.iso.org/fr/standard/38421.html
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes
ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971:2007, Medical Devices—The application of risk management to medical devices, a product safety standard. The standard provides a process framework and associated requirements for management responsibilities, risk analysis and evaluation, risk controls and lifecycle risk management.
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- How to develop a smartphone App to be FDA-cleared or CE Marked? - part 2 IEC 62304 and agile methods
- How to develop a smartphone App to be FDA-cleared or CE Marked? - part 3 Wireless
- How to develop a smartphone App to be FDA-cleared or CE Marked? - part 4 Usability
- How to develop a smartphone App to be FDA-cleared or CE Marked? - part 5 Deployment
- How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion
- How to bring legacy software into line with IEC 62304? - part 1
- How to bring legacy software into line with IEC 62304? - part 2
- How to bring legacy software into line with IEC 62304? - part 3