ISO 13485: 2003 is an international standard to enable medical device manufacturers to demonstrate an effective quality management system. This standard applies to all organizations that are active in the supply chain or are regulated in putting devices through the relevant EU directives involved (medical devices, in vitro diagnostics, medical devices, which can be actively implanted) in circulation. this standard which is EN ISO13485: 2012 harmonized at European level, with policies in Europe. Therefore, certification acc. this standard is mandatory for manufacturers of medical devices in Europe and increasingly required by their suppliers.der Standard specifies requirements for all types of medical equipment, the gem also services and,. on amending the Statute at European level (Directive 2007/47 / EC), Software. The devices range from sterile non-sterile, invasive non-invasive medical devices and non-active medical devices, active implants.In course of the directives, the safety and declared conformity assessment procedures functionality of medical devices must be so shown that these products may be entered , As gem for conformity assessment in Europe. Annex II (Full Quality Assurance System) and Annex V (quality assurance in production), evidence of a quality management system is to sell an important prerequisite for obtaining registration, thus introducing the right to medical devices in Europe or around them on the market (CE mark) .ISO 13485 has some features that are congruent placed with those of other management systems, particularly ISO 9001 having to another focus, to ensure compliance with quality-related and risk management in accordance with laws. ISO 14,971th
The benefits for organizations not only in the application aspects, but also in the transparency of its own performance of organizations, operations following defined processes and the fact that the Organisation of law made changes. In addition, can help effective measures for risk management to minimize and thus the control of risks associated with the set.
All organizations involved in development and manufacture of medical devices and marketing.
ISO13485: 2003 - Medical Device Quality Management System
Training and certification of person
Course number Medical Quality Management Systems
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