As indicated in the EU MDD/MDR and UK MDR, standalone software which has a medical purpose is considered to be an active medical device. Classification depends on the risk to the patient and users. To classify your software fully, you will need to review the relevant classification rules. Q...
With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework ...
In general, the path towards obtaining the CE marking depends on the medical device’s class. Since, in the light of the EU MDR, Medical Device Software is considered as an active medical device, the majority will undergo the upclassification and will belong at least to class IIa. As per ...
M. McHugh, F. McCaffery, and V. Casey, "Standalone Software as an Active Medical Device " presented at the The 11th International SPICE Conference Process Improvement and Capability dEtermination, Dublin, 2011.McHugh, M et al: Standalone Software as an Active Medical Device. The 11th ...
its suitability for medical device software is a more complex question. Medical device software has unique requirements, including real-time performance, regulatory compliance, safety-critical systems, and long-term support—all of which must be carefully considered when choosing a development framework....
IEC 80001 is currently undergoing revision. While the main points are still considered to be sound, the lack of drivers for implementation and the complexity of some of the standard are being considered in the revision.xvii Show more View chapterExplore book ...
Active user community continually adding templates, tutorials, and more Notion Cons Steep learning curve for beginners and non-tech users Performance issues loom as databases grow larger Asynchronous collaboration and notifications can be problematic ...
Donald Norman’s concept of determining a user’s “mental model” has become widespread in the software usability community, and is now considered a core design challenge.** See Donald Norman’s book The Design of Everyday Things (2002), p9. However, Norman described this concept in the ...
(NAB booth N1516) , are launching support within axle ai 2022 for XenData’s X100 active archive. The resulting combination of browser-based search, media management, AI tagging and editing with robust back end storage facilities is ideal for creative video, medical imaging, video surveillance ...
Stephan is considered a key industry thought leader on risk management, and has provided multiple training sessions to medical device manufacturers on structured risk management process per EN ISO 14971 & EU MDD 93/42 as amended with directive 2007/ 47. Mr. Buttron has also provided countless ...