Professional Certificate in ISO 13485 for Professionals
-- ViewingNowThe Professional Certificate in ISO 13485 for Professionals is a comprehensive course designed to equip learners with the essential skills needed to excel in the medical device industry. This course focuses on the importance of ISO 13485, an international standard for quality management systems specific to the medical device industry.
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Here are the essential units for a Professional Certificate in ISO 13485 for Professionals:
⢠Introduction to ISO 13485: Understanding the standard, its purpose, and its benefits for medical device organizations.
⢠Quality Management System (QMS) Requirements: Overview of the QMS requirements and expectations for ISO 13485 certification.
⢠Risk Management in ISO 13485: Identifying and managing risks in medical device organizations in compliance with ISO 13485.
⢠Design and Development Controls: Implementing design and development controls to meet the requirements of ISO 13485.
⢠Production and Service Controls: Managing production and service controls to ensure compliance with ISO 13485.
⢠Measurement, Analysis, and Improvement: Implementing measurement, analysis, and improvement processes to meet the requirements of ISO 13485.
⢠Internal Audit and Management Review: Conducting internal audits and management reviews to ensure compliance with ISO 13485.
⢠Preparing for ISO 13485 Certification: Steps for preparing for and achieving ISO 13485 certification.
⢠Maintaining ISO 13485 Certification: Best practices for maintaining ISO 13485 certification and continuous improvement.
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