USA | ProSolv® CardioVascular Solutions USA | ProSolv® CardioVascular Solutions
ProSolv has been assessed as meeting the requirements of ISO 13485 (certificate number CA04/3201). ISO 9001 is a general standard defining quality system requirements. ISO 13485 provides particular requirements for suppliers of medical devices that are more specific than the general requirements of ISO 9001. In conjunction with ISO 9001, this International Standard defines the requirements for quality systems relating to the design/development, production, installation and servicing of medical devices.
It embraces all the principles of good manufacturing practice (GMP) widely used in the manufacture of medical devices. ISO is a network of the national standards institutes of some 140 countries, with a central office in Geneva, Switzerland, that coordinates the system and publishes the finished standards. When the large majority of products or services in a particular business or industry sector conform to International Standards, a state of industry-wide standardization can be said to exist. This is achieved through consensus agreements between national delegations representing all the economic stakeholders concerned - suppliers, users and, often, governments. They agree on specifications and criteria to be applied consistently in the classification of materials, the manufacture of products and the provision of services. In this way, International Standards provide a reference framework, or a common technological language, between suppliers and their customers - which facilitates trade and the transfer of technology.
