Certificate in ISO 13485: Practical Guide
-- ViewingNowThe Certificate in ISO 13485: Practical Guide is a comprehensive course that provides learners with essential skills for career advancement in the medical device industry. This course focuses on the practical implementation of ISO 13485, the international standard for medical device quality management systems.
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โข Introduction to ISO 13485
โข Benefits and Importance of ISO 13485 Certification
โข Overview of ISO 13485:2016 Requirements
โข Scope and Application of ISO 13485 Standard
โข Key Principles and Clauses of ISO 13485
โข Management Responsibilities and Commitment
โข Resource Management in ISO 13485
โข Risk Management for Medical Devices
โข Design and Development Controls
โข Production, Installation, and Service
โข Measurement, Analysis, and Improvement in ISO 13485
โข Internal Audits and Management Review for Continuous Improvement
โข Preparing for and Implementing ISO 13485 Certification Audit
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