As medical technology evolves, software-driven medical devices are playing an increasingly important role in diagnostics, patient monitoring, and treatment delivery. However, these innovations bring complex legal and regulatory challenges, including FDA approval, cybersecurity compliance, intellectual property rights, liability risks, and international regulatory adherence. Failure to comply with legal requirements can lead to product recalls, lawsuits, regulatory penalties, and reputational damage.
This course provides an in-depth legal analysis of compliance requirements for medical device software, covering FDA and international regulations, cybersecurity laws, intellectual property protections, clinical validation requirements, and liability risk management. Students will gain expertise in navigating regulatory approval pathways, mitigating legal risks, and ensuring compliance with evolving software-as-a-medical-device (SaMD) regulations.
Course Objectives
By the end of this course, students will:
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Understand the Legal and Regulatory Framework for Medical Device Software – Analyze FDA regulations, global compliance standards, and the role of SaMD (Software as a Medical Device).
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Evaluate the FDA Approval and Compliance Process for Medical Software – Learn how to classify and submit medical device software for FDA clearance or approval.
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Examine Liability and Risk Management Strategies in Medical Device Software – Study how to prevent lawsuits, mitigate product liability risks, and ensure patient safety.
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Analyze Data Privacy, Cybersecurity, and HIPAA Compliance in Medical Software – Review how cybersecurity laws and patient data protections apply to medical device software.
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Assess Intellectual Property (IP) and Patent Protection for Medical Software Innovations – Develop strategies for protecting software patents, trade secrets, and proprietary algorithms.
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Explore International Regulatory Challenges for Global Medical Software Compliance – Investigate how to navigate EU MDR (Medical Device Regulation), GDPR, and other global laws.
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Identify Best Practices for Contracting, Licensing, and Vendor Compliance in Medical Software Development – Learn how to structure agreements to minimize legal exposure.
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Prepare for Future Trends and Legislative Changes Affecting Medical Software Compliance – Examine emerging regulations, AI-driven compliance models, and evolving legal risks.
