Certificate in ISO 13485: Foundations for Success
-- ViewingNowThe Certificate in ISO 13485: Foundations for Success is a comprehensive course designed to provide learners with a solid understanding of ISO 13485, the international quality standard for medical devices. This course is essential for professionals seeking to advance their careers in the medical device industry, where compliance with regulatory requirements is crucial.
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โข Introduction to ISO 13485: Understanding the Standard and its Importance
โข Key Principles and Clauses of ISO 13485: Quality Management System Requirements
โข Medical Device Industry Context: Relevant Regulations, Guidelines, and Best Practices
โข Implementing ISO 13485: Practical Steps, Tools, and Techniques
โข Documentation Control: Essential Records, Forms, and Procedures
โข Risk Management: Integrating ISO 13485 with ISO 14971
โข Internal Audits: Preparing, Conducting, and Reporting
โข Continuous Improvement: Monitoring, Measuring, and Analyzing Performance
โข Management Review: Effective Processes and Decision Making
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