Global Certificate in Device Regulations: Essentials
-- ViewingNowThe Global Certificate in Device Regulations: Essentials is a comprehensive course designed to provide learners with a solid understanding of the complex regulatory landscape governing medical devices. This course is critical for professionals involved in the development, production, or distribution of medical devices, as it ensures compliance with international regulations, reducing risks, and accelerating time-to-market.
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โข Global Device Regulations Overview: An introduction to the fundamental concepts and principles of global device regulations, including the role of regulatory agencies and the importance of compliance. โข Medical Device Classification: Explanation of the different classes of medical devices and the corresponding regulatory requirements in major global markets. โข Regulatory Pathways for Medical Devices: A review of the various regulatory pathways for medical device approval, including premarket approval (PMA), premarket notification (510(k)), and the de novo process. โข Labeling and Packaging Requirements: Overview of the labeling and packaging requirements for medical devices, including instructions for use (IFU), symbols, and language requirements. โข Clinical Data and Evaluation: Discussion of the clinical data and evaluation requirements for medical devices, including clinical trials, post-market surveillance, and benefit-risk analysis. โข Quality System Regulations: Explanation of quality system regulations, including the international standard ISO 13485 and the U.S. Food and Drug Administration's Quality System (QS) regulation. โข Post-Market Surveillance and Vigilance: Overview of post-market surveillance and vigilance requirements for medical devices, including adverse event reporting and recalls. โข Global Harmonization and International Regulations: Discussion of global harmonization and international regulations for medical devices, including the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF).
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