According to ISO 13485: 2016, a medical device is understood to be an instrument, tool, equipment, computer program, implant, reagent, material or other article intended by the manufacturer to be used in people, separately or in combination, with any of the following specific medical purposes:
that do not exert their intended main action inside or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function such mechanisms may contribute.
As examples of sanitary products, we put the following:
UNE-EN ISO 13485 determines the requirements of a quality management system for organisations involved in one or more stages of the life cycle of a medical device. Therefore, it can cover the design and development, production, storage and distribution, installation, technical assistance and the final uninstallation and disposal of medical devices as well as the design and development or provision of related services (example, technical support).
ISO 13485 is also applied by suppliers, subcontractors or other external parties supplying products (e.g. raw materials, components, sub-assemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to organisations and healthcare facilities.
ISO 13485: 2016 was based on UNE-EN ISO 9001: 2008 and does not have the structure of other more modern standards (in its annexe B it shows the correspondence between this international standard and ISO 9001: 2015).
Our consulting services are intended to help the company to the interpretation of the standard, and design and prepare the entire documentary base that is going to be required.
After the implementation and improvement process, we provide support to the organisation in the certification inspection (Aenor, BSI, Lloyd’s Register, DNV GL Business Assurance, Bureau Veritas…).
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Company registration certification UNE-EN ISO 13485. Bodies that certify this standard: Aenor, BSI, Lloyd´s Register, DNV GL Business Assurance, Bureau Veritas…