This course explores ISO 13485, the international standard for Quality Management Systems in medical device manufacturing. Participants will learn about regulatory requirements, product safety, and risk management in medical device production.
This course explores ISO 13485, the international standard for Quality Management Systems in medical device manufacturing. Participants will learn
This course explores ISO 13485, the international standard for Quality Management Systems in medical device manufacturing. Participants will learn about regulatory requirements, product safety, and risk management in medical device production.
1. Implement ISO 13485 medical devices quality management principles.
2. Ensure compliance with regulatory requirements in medical device manufacturing.
3. Develop risk management and quality control strategies.
4. Conduct audits and maintain product traceability.
5. Improve safety and effectiveness of medical devices.
1. Establish ISO 13485 compliance for medical device manufacturing.
2. Develop risk management and product safety measures.
3. Conduct regulatory audits and traceability documentation.
4. Maintain quality control in medical device production.
5. Achieve ISO 13485 certification readiness.
1. Medical device manufacturers
2. Quality assurance professionals
3. Regulatory affairs specialists
4. Research and development teams
5. Medical product safety officers.
