對已識別危害的相關風險的估計是否充分 (Adequacy on the estimation of related risk for each identified hazard)；
Examining the information with regards to their security and efficiency is a large challenge mainly because the standard of clinical info differs widely from study to check depending on Basic safety, threat-benefit profile, General performance & Acceptability of Unintended effects.
Determine the Scope in the medical machine: The clinical evaluation prepare must Plainly define the unit’s scope, supposed use, patient inhabitants, and clinical indications.
While in the absence of usability data: An evaluation in the literature did not uncover any supplemental insights concerning the usability factors linked to the use of the . Furthermore, there is not any indicator while in the literature of any overarching item concerns or style flaws related to usability.
It is necessary to possess a technique that Evidently defines your methodology adopted in examining the information.
Lastly – and Clinical evaluation report for medical devices this is the huge attribute in the regulation – entry to the information of the equal machine (to its technical documentation) have to be verified. For course III and IMD this will likely essentially include a agreement among the producers, most often competitors.
Adequacy with the maker’s data resources, In case the intended goal and threat reduction actions are satisfactory, discrepancies.
You should offer a summary with the usability engineering both deriving from independent documents or the risk management.
Current available post-industry surveillance data and delineate its significance in evaluating the clinical effectiveness and safety of the appropriate medical gadget.
「臨床證據」是指，和目標醫材相關的臨床資料與臨床評估結果，且具有足夠的資料量與品質，可用來評估目標醫材依製造廠預期來使用時是否安全，以及是否有達到預期臨床效益。
You’ll be drawing on clinical info and sources from literature and cross-referencing Individuals files Together with the statements they guidance. It’s a prolonged and time-consuming method without the right Instrument to assist you.
A clinical evaluation might also be according to clinical information referring to a medical unit for which equivalence for the machine less than evaluation may be demonstrated.
Require clinical, regulatory, and technical professionals in making ready the clinical evaluation report documentation to make sure an extensive and robust evaluation
Communication With all the Skilled Authorities: Manufacturers could be necessary to communicate with the notified bodies often to report on the security and overall performance in the product.