Certificate in IVD Market Authorization
-- ViewingNowThe Certificate in IVD Market Authorization course is a comprehensive program designed to equip learners with the essential skills needed to navigate the complex world of in vitro diagnostic (IVD) device regulation. This course is critical for professionals working in or seeking to enter the IVD industry, where regulatory compliance is paramount.
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โข IVD Regulations and Guidelines: Understanding the legal framework and industry standards for In Vitro Diagnostic (IVD) Market Authorization, including the European In Vitro Diagnostic Medical Devices Regulation (IVDR) and the US Food and Drug Administration (FDA) regulations.
โข Quality Management System (QMS): Implementing and maintaining a QMS for IVD devices, including the requirements of ISO 13485 and the Medical Device Single Audit Program (MDSAP).
โข Clinical Evidence and Performance Evaluation: Designing and conducting clinical studies to generate evidence of the safety, performance, and effectiveness of IVD devices, in accordance with the MEDDEV 2.7/1 rev. 4 guidelines.
โข Technical File Preparation: Compiling and submitting technical documentation for IVD Market Authorization, including the device description, design and manufacturing information, and risk management file.
โข Post-Market Surveillance and Vigilance: Monitoring and reporting adverse events, malfunctions, and performance issues of authorized IVD devices, in compliance with the applicable regulations and guidelines.
โข Labeling, Instructions for Use (IFU), and Promotional Materials: Creating and reviewing labeling, IFU, and promotional materials for IVD devices, ensuring compliance with the relevant regulations and guidelines.
โข Notified Body Engagement: Selecting, engaging, and managing the relationship with a Notified Body for CE Marking of IVD devices, in accordance with the IVDR and MDSAP requirements.
โข US FDA Premarket Approval (PMA) and 510(k) Submissions: Preparing and submitting PMA and 510(k) applications for IVD Market Authorization in the US, in accordance with the FDA regulations and guidelines.
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