The International Organization of Standards (ISO) is a worldwide federation of member bodies within a specific technical skill set that is responsible for the draft and release of global medical device regulations. In 1996, the ISO established guidance ISO 13485:2003 under the jurisdiction of the ISO / International Electrotechnical Commission (IEC) Directive, Part 1 to offer direction on quality management system (QMS) requirements for organizations that design or manufacture medical devices and associated components.
In 2016, original guidance ISO 13485:2003 was amended to further emphasize the importance of a risk-based approach to QMS implementation for effective maintenance, revised under ISO / IEC Directive, Part 2. The newly updated guidance, ISO 13485:2016, requires that all global medical device manufacturers are fully compliant by March 31, 2019 to ensure that certification audits beginning April 1, 2019 stand in conformance.
We invite you to read our white paper, “ISO 13485:2016: Effective Preparation and Implementation of Medical Device Quality Management Systems” to better understand how your organization can effectively prepare for success under the new guidelines.
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