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For randomised clinical trials, the Jadad scale ( To complement the Jadad score, the Cochrane Risk of Bias Tool (RoB 2) (Sterne et al., 2019) was also used for RCTs to provide a domain-based qualitative evaluation, assessing risks related to selection, performance, detection, attrition, and reporting
The classification order includes mitigation measures, including biocompatibility evaluations, clinical and non-clinical performance testing, electrical, thermal, and mechanical safety testing, electromagnetic compatibility testing, and labeling changes
10.1097/TA.0b013e31822a3254 106 Zivanovic-PosilovicG.BalenovicD.BarisicI.StrinicD.StambolijaV.UdovicicM.et al (2016)