Certificate in Medical Device Compliance Principles
-- ViewingNowThe Certificate in Medical Device Compliance Principles course is a comprehensive program that equips learners with the essential skills needed for success in the medical device industry. This course emphasizes the importance of regulatory compliance, quality management, and risk management in the development, manufacturing, and distribution of medical devices.
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โข Medical Device Regulations: An overview of the legal and regulatory framework governing medical devices, including FDA regulations, European Medical Device Directives, and international standards.
โข Quality Management Systems: An introduction to quality management systems (QMS) and their role in medical device compliance, including ISO 13485 and FDA Quality System Regulation.
โข Design Controls: An examination of design controls in medical device development, including requirements, design inputs, design outputs, and design reviews.
โข Risk Management: An exploration of risk management in medical devices, including risk assessment, risk evaluation, and risk controls.
โข Labeling and Packaging: A review of labeling and packaging requirements for medical devices, including UDI (Unique Device Identification) and instructions for use.
โข Clinical Evaluation: An examination of clinical evaluation and clinical data requirements for medical devices, including clinical investigations and performance evaluations.
โข Post-Market Surveillance: An overview of post-market surveillance and vigilance, including adverse event reporting, product recalls, and field corrections.
โข Supply Chain Management: An exploration of supply chain management in medical devices, including supplier selection, quality agreements, and supplier audits.
โข Change Management: A review of change management in medical devices, including change control, validation, and verification.
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