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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⢠Introduction to ISO 13485 – Overview, Benefits, and Scope
⢠Understanding the ISO 13485 Framework – Clauses and Requirements
⢠Establishing a Quality Management System (QMS) for ISO 13485
⢠Implementing and Monitoring ISO 13485 QMS
⢠Management Responsibility and Resource Management in ISO 13485
⢠Product Realization and Measurement, Analysis, and Improvement
⢠ISO 13485:2016 Changes and Transition Considerations
⢠Risk Management in ISO 13485 – Integrating ISO 14971
⢠Internal Audits and Management Review for ISO 13485
⢠Preparing for ISO 13485 Certification – Documentation, Gap Analysis, and Registration Audit
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