Professional Certificate in Regulatory Affairs for IVD Compliance
-- ViewingNowThe Professional Certificate in Regulatory Affairs for IVD Compliance is a crucial course for professionals seeking to navigate the complex world of in vitro diagnostic (IVD) regulation. This program focuses on the importance of regulatory compliance in the IVD industry, addressing the latest FDA and EU regulations.
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⢠Regulatory Foundations for IVD Compliance: Understanding the legal and regulatory framework governing In Vitro Diagnostic (IVD) devices, including global regulations, guidelines, and standards.
⢠Quality Management Systems (QMS) for IVDs: Establishing and maintaining a robust QMS in compliance with ISO 13485 and other relevant standards, focusing on design control, document control, and corrective and preventive action (CAPA).
⢠IVD Classification and Risk Management: Identifying and classifying IVD devices based on risk levels and implementing risk management strategies to minimize potential harm to patients and users, in alignment with ISO 14971.
⢠Labeling, Instructions for Use (IFU), and Promotion: Designing and implementing compliant labeling, IFU, and promotional materials, adhering to regional and global regulations, such as EU MDR, FDA, and IVDR.
⢠Clinical Evidence and Performance Evaluation: Developing and executing clinical evidence strategies, performance evaluation plans, and post-market clinical follow-up studies to demonstrate the safety, performance, and effectiveness of IVD devices.
⢠Post-Market Surveillance and Vigilance: Implementing and managing post-market surveillance and vigilance programs, ensuring timely reporting of adverse events and field corrective actions to regulatory authorities, in accordance with MEDDEV 2.12-1 rev. 8 and ISO 13485.
⢠Regulatory Submissions and Approvals: Preparing and submitting technical documentation, applications, and notifications to regulatory agencies, such as FDA 510(k) premarket notifications, EU MDR/IVDR technical files, and Australian TGA submissions.
⢠Supply Chain Management and Distribution: Managing suppliers, contract manufacturers, and distribution channels in compliance with regulatory requirements, including UDI (Unique Device Identification) regulations.
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