Clinical evaluation
Systematic, planned and documented process by which the clinical data of the medical device is collected, analyzed and evaluated to verify its safety and operation.
Clinical evaluation is an iterative, systematic, planned, documented and continuous process of evaluating data and information that allows the manufacturer, through its analysis and evaluation, to guarantee the clinical safety of the medical device.
The clinical evaluation will be thorough and objective, taking into account both favorable and unfavorable data.
Their scope, depth and breadth shall be proportionate to the nature, classification, intended purpose and foreseeable risks of each product.
The assessment may be based on clinical data of devices from which sound conclusions can be drawn due to their similarity and equivalence, as well as on clinical research carried out in order to verify product conformity.
In the analysis of equivalent products , the technical, biological and clinical characteristics of the devices will be taken into account, to the extent that the differences do not imply clinical differences regarding their clinical safety and performance of the product, always basing the equivalences on scientific data justified by the manufacturer.
Clinical Research
In the case of clinical investigations, they will always comply with the applicable principles and requirements and will be documented in reports that will support the clinical evaluation of the product.
Product Compliance
The collection of clinical and non-clinical data will allow the manufacturer to demonstrate the conformity of the product based on the safety and performance requirements applicable to each.
If you need help, guidance, or support with the clinical evaluation of your product, please contact us and we will work to develop the best solution.
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