Medical Device Design and Regulation

  1. Regulatory Foundations
    1. The U.S. Food and Drug Administration
      1. Structure and Functions
        1. Center for Devices and Radiological Health
          1. Responsibilities and Scope
            1. Device Classification and Oversight
            2. The Federal Food, Drug, and Cosmetic Act
              1. Key Provisions for Devices
                1. Amendments Affecting Devices
                2. Code of Federal Regulations
                  1. Title 21 CFR Part 820
                    1. Quality System Requirements
                      1. Enforcement and Inspections
                      2. Title 21 CFR Part 812
                        1. Requirements for Clinical Investigations
                        2. Title 21 CFR Part 814
                          1. PMA Application Process
                            1. Post-Approval Requirements
                            2. Title 21 CFR Part 807
                              1. Registration and Listing
                                1. 510(k) Submission Process
                            3. International Regulatory Bodies and Standards
                              1. European Union Medical Device Regulation
                                1. Scope and Applicability
                                  1. Conformity Assessment Procedures
                                    1. Notified Bodies
                                    2. International Organization for Standardization
                                      1. ISO 13485
                                        1. Structure and Requirements
                                          1. Certification Process
                                          2. ISO 14971
                                            1. Risk Management Principles
                                              1. Integration with QMS
                                            2. International Medical Device Regulators Forum
                                              1. Mission and Activities
                                                1. Harmonization Efforts

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                                            2. The Medical Device Lifecycle

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                                            4. Medical Device Classification