What is Clinical Evaluation and Investigation?

 

Clinical evaluation is an iterative, systematic, planned, documented and continuous process of data and information evaluation that allows the manufacturer, through its analysis and evaluation, to guarantee the clinical safety of the medical device.

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The clinical evaluation will be exhaustive and objective, taking into account both favorable and unfavorable data.

Its scope, depth and breadth will be proportional to the nature, classification, intended purpose and foreseeable risks of each product.

The evaluation may be based on clinical data of products from which solid conclusions can be drawn due to their similarity and equivalence, as well as clinical investigations carried out in order to verify product conformity.

In the analysis of equivalent products, the technical, biological and clinical characteristics of the products will be taken into account, to the extent that the differences do not imply clinical differences related to their safety and clinical functioning of the product, always basing the equivalences on scientific data justified by the manufacturer.

CLINICAL INVESTIGATIONS

 

In the case of clinical research, 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 Report of your product, contact us and we will work to develop the best solution.

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