Certificate in ISO 13485: A Comprehensive Overview
-- ViewingNowThe Certificate in ISO 13485: A Comprehensive Overview course is a vital program for professionals seeking to excel in the medical device industry. This certification focuses on ISO 13485, an internationally recognized standard for quality management systems in medical device manufacturing.
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⢠Introduction to ISO 13485: Understanding the standard, its purpose, and benefits in the medical devices industry.
⢠ISO 13485 Requirements: Comprehensive review of the clauses and requirements in ISO 13485.
⢠Quality Management System (QMS): Design and implementation of a QMS according to ISO 13485.
⢠Documentation Control: Establishing and maintaining documented information in compliance with the standard.
⢠Management Responsibilities: Defining management roles, responsibilities, and authorities.
⢠Resource Management: Managing human, infrastructure, and work environment resources.
⢠Product Realization and Lifecycle: Implementing processes for product realization and lifecycle management.
⢠Measurement, Analysis, and Improvement: Monitoring, measurement, and analysis for continuous improvement.
⢠Preparing for ISO 13485 Certification: Steps and best practices for successful certification.
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