Professional Certificate in ISO 13485: Future-Ready
-- ViewingNowThe Professional Certificate in ISO 13485: Future-Ready is a comprehensive course designed to equip learners with the necessary skills 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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⢠Introduction to ISO 13485: Understanding the Standard & Its Future Relevance
⢠Key Principles & Core Elements of ISO 13485:2016 for Medical Device Quality Management System
⢠Risk Management & ISO 13485: Implementing Risk-Based Approach in Medical Device QMS
⢠Documentation Requirements in ISO 13485: Developing & Maintaining Effective Procedures & Records
⢠Role of Management Responsibility & Resource Management in ISO 13485 Compliance
⢠Product Realization & ISO 13485: Design, Development, Production, & Service Controls
⢠Measurement, Analysis, & Improvement in ISO 13485: Monitoring, Measuring, Analyzing, & Evaluating Performance
⢠Preparing for & Managing ISO 13485 Certification: Best Practices & Common Challenges
⢠Maintaining ISO 13485 Certification & Continuous Improvement: Internal Audits, Management Review, & Corrective Action
⢠Future-Proofing Your ISO 13485 QMS: Emerging Trends, Technologies, & Regulatory Changes
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