Elaboración del expediente técnico para el marcado CE de productos de ONCOREC Diagnostics

Torres Rodríguez-Arana, Ana (2019). Elaboración del expediente técnico para el marcado CE de productos de ONCOREC Diagnostics. Proyecto Fin de Carrera / Trabajo Fin de Grado, E.T.S. de Ingeniería Agronómica, Alimentaria y de Biosistemas (UPM), Madrid.

Description

Title: Elaboración del expediente técnico para el marcado CE de productos de ONCOREC Diagnostics
Author/s:
  • Torres Rodríguez-Arana, Ana
Contributor/s:
  • Ramírez Castillejo, María del Carmen
  • Peláez García, Miguel Ángel
Item Type: Final Project
Degree: Grado en Biotecnología
Date: July 2019
Subjects:
Faculty: E.T.S. de Ingeniería Agronómica, Alimentaria y de Biosistemas (UPM)
Department: Biotecnología - Biología Vegetal
Creative Commons Licenses: Recognition - No derivative works - Non commercial

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Abstract

The project presented in this final degree work is the compilation of a dossier with the technical documentation required to acquire the CE mark through the implementation of a quality system according to the international standard UNE-EN-ISO 13485:2018. The medical product to be certified is an in vitro diagnostic device for colonic cancer relapse. The prediction of the disease’s recurrence is made by means of a blood sample analysis of 3ml every two/three months. The diagnosis is based on the screening of circulating tumour cells via the characterization of several surface markers of this type of cells. These cells are found in the bloodstream in very low proportion which are capable of migrating, producing metastasis, and therefore the relapse of the cancer. The current regulation on which the product to be certified is governed is Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, despite the fact that in a few years a new directive will be in place with certain changes in the procedure. According to the directive it is necessary that all products comply with the essential requirements. These are the obligations that the manufacturer has to assume in order to minimise risks, taking into account technical and economic considerations in order to be compatible with the protection of health and safety. In order to implement an effective quality management system, it is essential to standardize the entire procedure, from the moment the sample is taken to the final issue of the report with the results. This is done by technical diagnostic instructions that detail all the steps to follow to make a correct diagnosis. In order to obtain the CE certification, it is necessary to draw up the current CE Declaration of Conformity. This is essential for the quality management system, which are the set of rules and requirements that make it possible to meet the quality standards that a company requires to satisfy the requirements agreed with the customer. The QMS is carried out according to the international standard UNE-EN-ISO 13485:2018 which details the requirements that a quality management system must have for an organisation to demonstrate its capacity to provide health products. The most important document of the QMS is the quality manual, which is where the objectives and quality standards of a company are established. In this document we find the quality policies and instruments with which the company is committed to meet the objectives established. It is based on process management, where we can find strategic processes, key and support. Another of the key documentation required in the QMS is risk analysis, carried out thanks to the international standard UNE EN ISO 14971:2012, supplemented with other risks that may be associated with other activities following the standard UNE-EN-ISO 13485:2018. Finally, the types of documentation contained in the manual with their corresponding hierarchy are detailed.

More information

Item ID: 57162
DC Identifier: http://oa.upm.es/57162/
OAI Identifier: oai:oa.upm.es:57162
Deposited by: Biblioteca ETSI Agrónomos
Deposited on: 04 Nov 2019 12:41
Last Modified: 04 Nov 2019 12:41
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