Advanced Certificate in ISO 13485 for a Changing World
-- ViewingNowThe Advanced Certificate in ISO 13485 for a Changing World is a comprehensive course designed to equip learners with the essential skills needed to excel in the ever-evolving medical device industry. This certificate program focuses on the latest updates and revisions to ISO 13485, the international quality management system standard for medical devices, and emphasizes the critical role of risk management and change control in today's rapidly changing landscape.
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โข Introduction to ISO 13485:2016 & Changing Regulatory Landscape
โข Understanding Medical Device Quality Management System (QMS)
โข Risk Management in ISO 13485:2016
โข Design and Development of Medical Devices
โข Documentation and Record Keeping in ISO 13485:2016
โข Implementing and Maintaining ISO 13485:2016 QMS
โข Internal Audits and Management Review
โข Preparing for ISO 13485:2016 Certification
โข Continuous Improvement in a Changing World
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