Advanced Certificate in Medical Device Regulatory Compliance Strategies
-- ViewingNowThe Advanced Certificate in Medical Device Regulatory Compliance Strategies is a comprehensive course designed to equip learners with critical skills for career advancement in the medical device industry. This program focuses on essential regulatory strategies, ensuring that medical devices are compliant with industry standards and regulations, thereby reducing risks and ensuring patient safety.
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Here are the essential units for an Advanced Certificate in Medical Device Regulatory Compliance Strategies:
• Regulatory Framework for Medical Devices: An overview of the global regulatory landscape, including primary and secondary legislation, regulations, and guidance documents. This unit covers the US FDA, European Union MDR, and other international regulatory bodies.
• Quality Management Systems for Medical Devices: An in-depth exploration of quality management system requirements, including ISO 13485, FDA QSR, and MDSAP. This unit also covers quality system audits, inspections, and enforcement actions.
• Clinical Evaluation and Post-Market Surveillance: This unit covers clinical evaluation requirements, including the new EU MDR requirements for clinical evaluation reports. It also covers post-market surveillance, vigilance, and post-market clinical follow-up requirements.
• Risk Management for Medical Devices: An exploration of risk management principles and requirements, including ISO 14971 and FDA requirements. This unit covers risk identification, assessment, and mitigation strategies.
• Labeling, Promotion, and Advertising for Medical Devices: An examination of labeling, promotion, and advertising requirements, including FDA requirements and EU medical device regulations. This unit covers labeling content, format, and review processes, as well as promotional and advertising strategies.
• Medical Device Reporting and Complaint Handling: This unit covers medical device reporting requirements, including FDA Medical Device Reporting (MDR) and EU Vigilance reporting requirements. It also covers complaint handling, corrective and preventive actions (CAPA), and recalls.
• Combination Products and Cross-Cutting Issues: An exploration of combination products and cross-cutting issues,
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