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Showing posts with the label iso 13485 medical devices

ISO 13485:2016 Implementation and 2019 March Deadline – 2 hours Virtual Boot Camp

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OVERVIEW This 2-hour session will provide the attendees with experience gained in providing transition assistance to medical device companies over the last 2 years. Attendance includes examples of how to address the gaps most often observed and practical advice for managing transition activities as well as managing your certification audit for ISO 13485:2016. WHY SHOULD YOU ATTEND All organizations that are part of the medical device supply chain are required to establish a quality management system that conforms to ISO 13485. The transition period is coming to an end for the third edition of the standard and certifications to the second edition will expire by March 2019. If you haven’t completed the transition your organization may not be able to market devices in 2019 or you may have corrective actions forced on you by your customers. This webinar will provide you with practical actions you can take to ensure your certification to this new edition of the standard is obtaine...