Masterclass Certificate in ISO 13485 for the Modern Workplace
-- ViewingNowThe Masterclass Certificate in ISO 13485 for the Modern Workplace is a comprehensive course designed to empower professionals with the essential skills needed to excel in the medical device industry. This course focuses on 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 – Overview, Benefits, and Scope
โข Understanding the ISO 13485 Framework – Clauses and Requirements
โข Establishing a Quality Management System (QMS) for ISO 13485
โข Implementing and Monitoring ISO 13485 QMS
โข Management Responsibility and Resource Management in ISO 13485
โข Product Realization and Measurement, Analysis, and Improvement
โข ISO 13485:2016 Changes and Transition Considerations
โข Risk Management in ISO 13485 – Integrating ISO 14971
โข Internal Audits and Management Review for ISO 13485
โข Preparing for ISO 13485 Certification – Documentation, Gap Analysis, and Registration Audit
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