LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development.
Medical device software includes software components and independent software. Their management type, registration test and clinical evaluation are all different in the CFDA registration. It is really important for the manufacturer to distinguish the difference between software components and independent softwa...
In this paper the advantages of maintenance system architecture on the medical device management are shown and we are presenting original software that can be implemented in any hospital without being necessary the exis tence of a clinical engineering department....
One revolutionary development in digital health technology is software that can perform complex medical functions— software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management. Back to top Reimagining digital health regulation: An agile model ...
In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements management in the medical device industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. ...
Mobile Software as a Medical Device (SaMD) for the Treatment of Epilepsy: Development of Digital Therapeutics Comprising Behavioral and Music-Based Interve... Digital health technologies for people with epilepsy (PWE) include internet-based resources and mobile apps for seizure management. Since non...
The cloud-based operation of wearable medical devices enables medical professionals to monitor real-time vital parameters and to plan the requirement of physical visits, changes in therapy, and modalities for disease management. A schematic representation showing the work-flow behind cloud-based device ...
Regulators are approving more medical device software (MDSW) every year (e.g., theU.S. Food and Drug Administration cleared 135 MDSWs in 2023, 56% more than 2022).One in four medical devices is estimatedto be either MDSW themselves or contain medical device software. The ...
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