Module #1 Introduction to Regulatory Compliance in Medical Technology Overview of the importance of regulatory compliance in medical technology, including the role of regulatory agencies and the consequences of non-compliance.
Module #2 Global Regulatory Framework Overview of the global regulatory framework for medical technology, including the FDA, EUs MDR, and other international regulations.
Module #3 FDA Regulations for Medical Devices In-depth review of FDA regulations for medical devices, including classification, premarket notification, and postmarket surveillance.
Module #4 EUs Medical Device Regulation (MDR) In-depth review of the EUs MDR, including classification, conformity assessment, and CE marking.
Module #5 ISO 13485:Medical Device Quality Management Overview of the ISO 13485 standard for medical device quality management, including risk management and quality system requirements.
Module #6 Risk Management for Medical Devices Principles and practices of risk management for medical devices, including risk analysis, risk evaluation, and risk control.
Module #7 Labeling and Advertising Regulations Overview of labeling and advertising regulations for medical devices, including FDA and EU requirements.
Module #8 Clinical Trials and Investigational Device Exemptions (IDEs) Overview of clinical trials and IDEs, including FDA regulations and EU Clinical Trials Regulation.
Module #9 Postmarket Surveillance and Vigilance Overview of postmarket surveillance and vigilance requirements, including reporting of adverse events and product recalls.
Module #10 Medical Device Software and Cybersecurity Overview of medical device software and cybersecurity regulations, including FDA and EU requirements.
Module #11 Sterilization and Packaging Validation Overview of sterilization and packaging validation requirements for medical devices.
Module #12 Quality System Regulation (QSR) and Design Controls Overview of QSR and design controls, including design verification, design validation, and design transfer.
Module #13 Audits and Inspections Overview of audits and inspections, including FDA and EU requirements, and preparation strategies.
Module #14 Regulatory Submissions and Documentation Overview of regulatory submissions and documentation requirements, including 510(k), PMA, and CE marking technical files.
Module #15 Compliance for Medical Device Startups Special considerations for medical device startups, including regulatory strategy and resource management.
Module #16 Compliance for Medical Device Manufacturers Best practices for medical device manufacturers, including quality system implementation and continuous improvement.
Module #17 Compliance for Medical Device Distributors and Suppliers Special considerations for medical device distributors and suppliers, including supply chain management and contractual obligations.
Module #18 Regulatory Compliance for Digital Health and AI Overview of regulatory compliance for digital health and AI, including software as a medical device (SaMD) and artificial intelligence (AI) in medical devices.
Module #19 Compliance for Personalized Medicine and Companion Diagnostics Overview of regulatory compliance for personalized medicine and companion diagnostics, including genetic testing and precision medicine.
Module #20 Regulatory Compliance for Medical Device Clinical Trials Best practices for regulatory compliance in medical device clinical trials, including trial design and conduct.
Module #21 Regulatory Compliance for Medical Device Combination Products Overview of regulatory compliance for medical device combination products, including drug-device and biologic-device combinations.
Module #22 Regulatory Compliance for Medical Device Export and Import Overview of regulatory compliance for medical device export and import, including customs regulations and tariffs.
Module #23 Regulatory Compliance for Medical Device Labeling and Advertising Best practices for regulatory compliance in medical device labeling and advertising, including promotions and marketing materials.
Module #24 Regulatory Compliance for Medical Device Servicing and Repair Overview of regulatory compliance for medical device servicing and repair, including maintenance and refurbishment.
Module #25 Regulatory Compliance for Medical Device Disposal and Recycling Overview of regulatory compliance for medical device disposal and recycling, including environmental regulations.
Module #26 Regulatory Compliance for Medical Device Security and Privacy Overview of regulatory compliance for medical device security and privacy, including data protection and cybersecurity.
Module #27 Regulatory Compliance for Medical Device Standards and Harmonization Overview of regulatory compliance for medical device standards and harmonization, including international standards and consensus standards.
Module #28 Regulatory Compliance for Medical Device Packaging and Labeling Best practices for regulatory compliance in medical device packaging and labeling, including UDI and serialization.
Module #29 Regulatory Compliance for Medical Device Manufacturer Oversight Overview of regulatory compliance for medical device manufacturer oversight, including quality agreements and supply chain management.
Module #30 Course Wrap-Up & Conclusion Planning next steps in Regulatory Compliance in Medical Technology career
