Global Certificate in Healthcare Device Compliance Fundamentals
-- ViewingNowThe Global Certificate in Healthcare Device Compliance Fundamentals is a crucial course for professionals seeking expertise in the healthcare device industry. This certificate program focuses on essential compliance areas, including regulations, quality management, and clinical data management.
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⢠Regulatory Landscape in Healthcare Device Compliance: Understanding global regulations, standards, and guidelines for healthcare devices, including FDA, EU MDR, and IEC 60601.
⢠Risk Management in Healthcare Devices: Identifying and assessing risks in healthcare devices, applying risk management methodologies, and ensuring compliance with ISO 14971.
⢠Design Control and Documentation: Implementing design controls for healthcare devices, creating technical files, and maintaining design history files according to FDA and EU requirements.
⢠Quality Management Systems (QMS): Establishing and managing a QMS in alignment with ISO 13485 and FDA Quality System Regulation (QSR), and understanding the role of QMS in device compliance.
⢠Clinical Evaluation and Testing: Planning, conducting, and reporting clinical evaluations and testing for healthcare devices, and understanding the importance of clinical data in the compliance process.
⢠Labeling and Instructions for Use (IFU): Designing and implementing compliant labeling and IFU for healthcare devices, adhering to FDA, EU, and IEC 60601 requirements.
⢠Post-Market Surveillance and Vigilance: Implementing post-market surveillance programs, managing adverse event reporting, and understanding the role of post-market surveillance in continuous device compliance.
⢠Supply Chain Management and Distribution: Managing supply chain and distribution for healthcare devices, ensuring compliance with regulations, and understanding the importance of supply chain management in device compliance.
⢠Healthcare Device Cybersecurity: Understanding the importance of cybersecurity in healthcare devices, implementing cybersecurity measures, and ensuring compliance with industry standards and guidelines.
(Note: This list of units is not exhaustive and may vary based on the specific requirements of the Global Certificate in Healthcare Device Compliance Fundamentals.)
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