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#Bsi iso 13485 lead auditor training how to
You’ll learn how to interpret the verbiage of the 13485 Standard and apply it to your own organization. This course prepares you to perform effective audits of Medical Device Quality Management Systems. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems. There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.Īxeon is an Exemplar Global Certified Training Provider.ĭate / Registration 4-Day ISO 13485:2016 with FDA 21 CFR 820 Lead Auditor Training CourseĪxeon is an Exemplar Global Certified Training Provider. Improvements in the latest version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements, and a greater focus on post-market surveillance including complaint handling. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and diagnostic reagents. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. With the standard applicable to so many types of products, the revision was no easy task. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.
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ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 Medical Devices, FDA, EU MDR, & MDSAP Why was ISO 13485 revised?