Undergraduate Certificate in Quality Standards for Medical Devices
-- ViewingNowThe Undergraduate Certificate in Quality Standards for Medical Devices is a comprehensive course designed to equip learners with critical skills in ensuring medical device quality and compliance with industry standards. This certificate program emphasizes the importance of quality management systems, regulatory affairs, and risk management in the medical device industry.
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⢠Introduction to Quality Standards for Medical Devices: Overview of quality standards, regulations, and guidelines for medical devices
⢠Quality Management Systems (QMS): Principles and components of QMS, focusing on ISO 13485
⢠Design Control and Risk Management: Design and development process, risk management according to ISO 14971
⢠Medical Device Testing and Validation: Test methods, validation principles, and regulatory requirements
⢠Change Management and CAPA: Managing changes in the product lifecycle and Corrective and Preventive Action (CAPA) processes
⢠Supplier Quality Management: Selecting, evaluating, and monitoring suppliers, adhering to supply chain requirements
⢠Quality Assurance and Compliance: Ensuring compliance with regulations, standards, and conducting internal/external audits
⢠Medical Device Regulations and Standards: FDA requirements, EU Medical Device Regulation (MDR), and international standards
⢠Documentation and Training: Essential documentation, record-keeping, and staff training for quality management
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