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ISO 13485 - Medical Device Quality Management System
Overview
The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. Some of the additional requirements to ISO 9001 requirements relate to

•  design controls,
•  risk management,
•  environmental controls,
•  special processes (e.g. software validation),
•  traceability, record retention, and,
•  regulatory actions (such as vigilance),

ISO 13485: 2003 has been harmonised against the medical device directives.

•  Medical Devices Directive,
•  Active Implantable Médical Devises Directive,
•  In Vitro Diagnostic Directive,

This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.

Formal certification of quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous, for medical companies which export their products to the global market.

•  In the European Union, the fulfillment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices.
•  Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 by an accredited certification body.

Who Can Go For ISO 13485 Certification?

•  Companies who design, manufacture, distribute, install and service medical devices for the European and World markets.
•   Companies who manufacture OEM products which are sold under other company names.
•  Companies who design and/or manufacture medical device components or raw materials for the medical device market.
•  Companies selling, installing or servicing medical devices.
•  Consultants providing design services to the medical device market
•  Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc.

Benefits

For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. Since 2003 when ISO 13485 was first implemented and recognized by the Global Harmonization Task Force (GHTF), it has quickly become the model standard for the medical industry.
By becoming certified in the ISO 13485 standard your company will:
•  Increase the probability of making safe and effective medical devices
•  Meet regulatory requirements
•  Meet customer expectations
•  Help monitor the effectiveness of your supply chain

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