Quality in Healthcare
Undoubtedly, the quality management system in companies is highly relevant. Specifically, those who provide health services need to focus even harder on their quality system. As a result, they achieve continuous improvement in regulatory requirements and strategic planning. In other words, the minimum standards that an institution must have are the quality of its inputs and adequate infrastructure. Eventually, the quality of its final product comes above all equally valuable factors.
Naturally, the high quality in the biomedical sector streams down on the patient. In a way, it is crucial to maintain the satisfaction of the explicit and implicit needs of its users (patients and healthcare staff). Therefore, having a quality management scheme makes companies much more competitive. It also offers added value to the patient, thus obtaining products of the highest quality.
Quality at Mimetis
Mimetis has similarly implemented a management structure in which meets customer requirements. Additionally, it achieves compliance with the regulations necessary for the design, manufacture, and marketing of its products, being under the standard of European directives and decrees regulating medical devices.
ISO 13485 Medical Equipment standard
Correspondingly, 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. In effect, this system aims at establishing a set of harmonized regulatory requirements for medical systems within the health products sector. In short, it is the world benchmark of good practices.
European Medical Device Directive (MDD) 93/42 / EEC
In a similar fashion, Mimetis Biomaterials is in full compliance with the European Medical Device Directive (MDD) 93/42 / EEC. In fact, 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. That is to say, Mimetis Biomaterials has a clean room with controlled environments where Mimetis scientists carry out the production processes necessary for the production of quality medical devices. Without a doubt, Mimetis Biomaterials’ cleanroom meets the highest pollution control and cleaning standards within the medical device industry.
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