Quality Assurance

CE Marking
ISO 13485
BSI ISO 13485

The importance of the quality management system in the companies providing health services is based on continuous improvement, regulatory requirements and strategic planning. The minimum standards that an institution must have are the quality of its inputs, adequate infrastructure and above all the quality of its final product in addition to many other valuable factors.

The quality in the biomedical sector has to be focused on the patient, managing to maintain the satisfaction of the explicit and implicit needs of its users (patients and healthcare staff). Having a quality management system makes companies much more competitive and offers added value to the patient, thus obtaining products of the highest quality. Mimetis has implemented a management system in which it undertakes to meet customer requirements and achieve compliance with regulations necessary for the design, manufacture, and marketing of its products under the standard of European directives and decrees regulating medical devices.

Mimetis complies with the ISO 13485 Medical Equipment standard (certificate available here), an internationally recognized quality management system (QMS) for manufacturers of medical equipment and related services whose objective is to establish a set of harmonized regulatory requirements for medical systems. quality management within the health products sector; It is the world benchmark of good practices.

Mimetis Biomaterials complies with the legislation of the European Medical Device Directive (MDD) 93/42 / EEC. Each product developed by Mimetis carries the CE marking, granted by the European Union, in its outer packaging in evidence of compliance with the applicable requirements. Mimetis Biomaterials has a clean room with controlled environments in which the production processes necessary for the production of quality medical devices are carried out. The Mimetis Biomaterials cleanroom meets the highest pollution control and cleaning standards within the medical device industry.

Partners

Universidad Politecnica de Cataluña

Founded almost 50 years ago, UPC is a public university specializing in engineering, architecture, and science. It has a first-level teaching team and is a reference in the field of research, creating and leading international projects.

Union Europea

The European Union is the international political organization that, among other actions, grants grants for the development of new scientific projects that have a positive impact on the European economy.

This is the Catalan Agency for Competitiveness of the Company and its main function is to promote the territory’s business network and provide financing sources. Coordinates the Enterprise Europe Network in Catalonia and actively participates in European projects.

Ministerio de Ciencia e Innovación

It is part of the Ministry of Economy, Industry and Competitiveness and assumes competencies in scientific and technical research, development and innovation.

Biomaterials Biomechanics and Tissue Engineering

The Biomaterials, Biomechanics and Tissue Engineering Research Group (BBT) develops biomaterials for tissue regeneration and repair. Not only does it carry out basic research, but it also transfers knowledge to companies and hospitals in the sector.

CDTi Logo

It is in charge of the proposals and execution of the Government’s policies for the improvement of industrial, scientific, technological and innovation development in all sectors. It also executes the commercial and company support policy.