Clinical Evaluation of Standalone Software: Standalone software with a medical purpose is considered an active medical device, according to the EU MDD/MDR and the UK MDR. The danger to the patient and the users determines the classification. You’ll need to examine the appropriate categorization criteria to categorize your programme thoroughly. The importance of computer applications…
Clinical Evaluation of Equivalent Devices What extent of data on medical devices from other manufacturers does needed to demonstrate equivalence? FOR INSTANCE, Annex XIV (3) EU MDR refers to non-implantable devices of risk classes I – IIb. It specifies that manufacturers must provide clear evidence that they have sufficient access to the device’s data with…
A literature search is a systematic thorough search of all types of literature ( eg. Books, peer-reviewed articles, etc). Structured literature reviews are essential for the clinical evaluation of the medical devices. Medical device manufacturers need to plan and execute a dedicated strategy for literature monitoring, triage, and analysis, and the results of the analysis…