Masterclass Certificate in Mastering Medical Device Technology
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• Medical Device Regulations: Understanding FDA and EU MDR regulations, Quality System Regulation (QSR) and ISO 13485, and global regulations for medical device technology
• Medical Device Design and Development: Principles of medical device design, design control, human factors, and usability testing
• Materials and Manufacturing Processes: Material selection, manufacturing processes, and supply chain management in medical device technology
• Risk Management: Risk management strategies, failure modes and effects analysis (FMEA), and FDA post-market surveillance
• Clinical Trials and Validation: Clinical trial design and execution, statistical analysis, and validation of medical devices
• Medical Device Cybersecurity: Cybersecurity threats, vulnerabilities, and solutions in medical device technology
• Regulatory Affairs and Submissions: Preparing and submitting regulatory applications, including 510(k), PMA, and de novo
• Medical Device Patent Law: Intellectual property protection, patent law, and licensing agreements in medical device technology
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EntryRequirements
- BasicUnderstandingSubject
- ProficiencyEnglish
- ComputerInternetAccess
- BasicComputerSkills
- DedicationCompleteCourse
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- ThreeFourHoursPerWeek
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- OpenEnrollmentStartAnytime
- TwoThreeHoursPerWeek
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