Correspondencia entre los requisitos de calidad para la certificación de productos, la certificación de sistemas de gestión de la calidad y el registro médico de biomateriales.

There are many regulations for the design-development and the manufacture of biomaterials. The Center for Governmental Control of Medical Devices is the institution that evaluates this kind of products in Cuba, to guarantee safety and efficacy in their medical use. This evaluation requires the conformity with national or international technical standards. Certification of products and quality systems are carried out by the National Office for Standardization (NOS) and requires the compliance with pertinent national standards. Both evaluation processes demand from the manufacturer to keep a quality management system, including some requirements of the ISO 9000 standards. Quality system certification involves the compliance of the manufacturer requirements to guarantee customer satisfaction and the regulatory and technical requirements. In this paper the requirements of the quality system needed for product certification and medical registration in Cuba are discussed and their relation to ISO 9001 standard. Also, the results obtained by the Center of Biomaterials of Havana University in this field are shown. Nowadays, neither product certification nor regulatory requirements for medical registration include quality system requirements in the design development process, customer focus, continuous improvement, internal quality auditing or management revision. Product certification demands the control of documents, quality assay records, including specifications, having a difference with government assessment that does not have these requirements. For the medical registration, compliance with different requirements is claimed depending on the risk classification of the medical device. More requirements are asked for the assessment of Class III medical devices. Medical registration demands the control of supplies, product traceability and validation of special processes, specially the sterilization processes. ISO 9000 quality system certification includes the compliance with quality requirements demanded by product certification and medical registration. The Center of Biomaterials has implanted a ISO 9001:2000 Quality Management System (QMS) in design- development and production that has been certified by NOS, having a solid support for medical registration of new products in the field of medical materials and for product certification. An effort has to be done by Cuban medical devices manufacturers to implant and certify their QMS and also to develop national technical standards for products assessment. [ABSTRACT FROM AUTHOR]