Professional Certificate in ISO 13485 for Consultants
-- ViewingNowThe Professional Certificate in ISO 13485 for Consultants is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This certificate course emphasizes the importance of ISO 13485, an internationally recognized standard for quality management systems specific to the medical device industry.
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โข Introduction to ISO 13485 & Medical Device Quality Management System (QMS)
โข Understanding ISO 13485:2016 Requirements
โข Gap Analysis & Risk Management in ISO 13485
โข Documentation Control & Record Keeping in Medical Device QMS
โข Implementing ISO 13485: Roles, Responsibilities & Training
โข Internal Audits & Management Review for ISO 13485 Compliance
โข ISO 13485 Certification Process for Consultants
โข Maintaining & Improving ISO 13485 Medical Device QMS
โข Case Studies: Successful ISO 13485 Implementations
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