Masterclass Certificate in Mastering Medical Device Technology
-- ViewingNowThe Masterclass Certificate in Mastering Medical Device Technology is a comprehensive course designed to equip learners with essential skills for success in the medical device industry. This certificate program emphasizes the importance of understanding medical device technology, from design and development to regulatory compliance and market launch.
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โข Medical Device Regulations: Understanding FDA and EU MDR regulations, Quality System Regulation (QSR) and ISO 13485, and global regulations for medical device technology
โข Medical Device Design and Development: Principles of medical device design, design control, human factors, and usability testing
โข Materials and Manufacturing Processes: Material selection, manufacturing processes, and supply chain management in medical device technology
โข Risk Management: Risk management strategies, failure modes and effects analysis (FMEA), and FDA post-market surveillance
โข Clinical Trials and Validation: Clinical trial design and execution, statistical analysis, and validation of medical devices
โข Medical Device Cybersecurity: Cybersecurity threats, vulnerabilities, and solutions in medical device technology
โข Regulatory Affairs and Submissions: Preparing and submitting regulatory applications, including 510(k), PMA, and de novo
โข Medical Device Patent Law: Intellectual property protection, patent law, and licensing agreements in medical device technology
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