Advanced Certificate in ISO 13485 Essentials
-- ViewingNowThe Advanced Certificate in ISO 13485 Essentials is a comprehensive course designed to equip learners with the necessary skills to excel in the medical device industry. This course focuses on the ISO 13485 standard, a crucial requirement for organizations involved in the design, production, installation, and servicing of medical devices.
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โข Introduction to ISO 13485: Understanding the Standard
โข Key Principles of Quality Management Systems
โข Scope and Application of ISO 13485
โข Risk Management in Medical Devices
โข Documentation Requirements for Compliance
โข Design and Development Controls for Medical Devices
โข Production, Sterilization, and Monitoring Processes
โข Measurement, Analysis, and Improvement of Quality Systems
โข Internal Audits and Management Review
โข Preparing for and Managing ISO 13485 Certification
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