The GHTF has been replaced in the last few years by the International Medical Device Regulatory Forum (IMDRF) and is structured differently from the GHTF as only the regulators, that are primary members of the group, get to make many of the decisions. The GHTF guidelines are slowly becoming universal standards for design, manufacture, export and sales of various medical devices.
#ISO 13485 WIKI ISO#
ISO 13485 is now considered to be inline standard and requirement for medical devices even with " Global Harmonization Task Force Guidelines" (GHTF). This standard adopted by CEN as EN ISO 13485:2003/AC:2007 is harmonized with respect to the European medical device directives 93/42/EEC, 90/385/EEC and 98/79/EC. Several registrars also act as Notified Body.įor those medical devices requiring the pre-market involvement of a Notified Body, the result of a positive assessment from the Notified Body is the certificate of conformity allowing the CE mark and the permission to sell the medical device in the European Union.Ī very careful assessment of the company Quality Management System by the Notified Body, together with the review of the required Technical Documentation, is a major element which the Notified Body takes into account to issue the certificate of conformity to the company product(s). Although the European Union Directives do not mandate certification to ISO 9001 and/or ISO 13485 the preferred method to prove compliance to such standards is to seek its official certification which is issued by certifying organizations known as "Registrars".
One of the major requirements to prove conformity is the implementation of the Quality Management System according ISO 9001 and/or ISO 13485 and ISO 14971. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Directives 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. specific requirements for cleanliness of productsĬompliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements.
#ISO 13485 WIKI VERIFICATION#
specific requirements for verification of the effectiveness of corrective and preventive actions.specific requirements for documentation and validation of processes for sterile medical devices.specific requirements for inspection and traceability for implantable devices.focus on risk management activities and design control activities during product development.