Global Certificate in Medical Device Regulations & Compliance
-- ViewingNowThe Global Certificate in Medical Device Regulations & Compliance is a comprehensive course designed to equip learners with the essential skills needed for career advancement in the medical device industry. This course focuses on the importance of regulatory affairs and compliance, providing a solid understanding of global regulatory systems, quality management systems, and clinical trial regulations.
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⢠Global Medical Device Regulations Overview: Understanding the global regulatory landscape, including FDA (US), MHRA (UK), TGA (Australia), and MHLW (Japan) regulations.
⢠Quality Management Systems (QMS): Establishing and maintaining a QMS for medical device manufacturing, including ISO 13485 compliance.
⢠Medical Device Classification: Identifying medical device classes and understanding their respective regulatory requirements.
⢠Design Control and Risk Management: Implementing design controls and risk management processes in medical device development, including FMEA and ISO 14971.
⢠Clinical Evaluation and Trials: Conducting clinical evaluations and trials for medical devices, ensuring compliance with regulations and guidelines.
⢠Labeling and Packaging Requirements: Meeting global labeling and packaging requirements for medical devices, including UDI and e-labeling.
⢠Post-Market Surveillance and Vigilance: Implementing post-market surveillance and vigilance programs, complying with MDR (EU) and other global regulations.
⢠Medical Device Reporting and Complaint Handling: Managing medical device reporting and complaint handling processes, adhering to FDA, MHRA, and other global requirements.
⢠Regulatory Inspections and Audits: Preparing for and managing regulatory inspections and audits, understanding the implications and response strategies.
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