The certificate course “Mastering ISO 13485 – Quality Management System for Medical Devices” is designed to provide comprehensive knowledge and practical skills in implementing and maintaining a quality management system (QMS) for medical devices in accordance with the ISO 13485 standard. This course is essential for individuals working in the medical device industry, including manufacturers, regulatory affairs personnel, quality assurance professionals, and auditors.
Course Objectives:
- Gain a thorough understanding of the ISO 13485 standard and its requirements for QMS in the medical device industry.
- Learn essential techniques for implementing and maintaining a quality management system tailored to medical device regulations.
- Acquire the necessary skills to ensure compliance with international regulatory requirements and standards, including those of the European Union, Canada, and the United States.
- Develop expertise in designing and controlling medical devices in alignment with ISO 13485 and FDA 21 CFR Part 820.
Topics:
- Introduction to ISO 13485 standard for medical devices quality management system.
- Understanding the key elements and requirements of ISO 13485 for QMS in the medical device industry.
- Software tool validation and its importance in the context of medical device manufacturing.
- Gain a competitive advantage by mastering ISO 13485 and implementing effective quality management systems.
