Intended purpose
It is defined as the intended use of a product according to the information provided by the manufacturer on the labelling, instructions for use or promotional and sales material or claims, as indicated by the manufacturer in the clinical evaluation.
All this is part of the technical file, where it will be clearly identified due to its vital relationship with the essential product requirements . From the binomial Intended Purpose and Applicable Requirements , the risk management designed for the quality management system will be extracted, based on harmonized standards UNE-EN ISO 14971, or not, aimed at eliminating foreseeable risks and reducing residuals.
The intended purpose is identified by the manufacturing company, documented in the technical product file and in the information provided by the manufacturer, providing patients and users with the greatest degree of detail on the operation of the product, and thus reducing possible risks derived from the lack of experience or prior technical knowledge of the operation of the product.
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