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Communication Strategies. Case Studies. Applied Knowledge.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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SECTION I: Fundamentals of US Medical Device Regulations Chapter 1: History of Food, Drug, and Cosmetic Laws Chapter 2: Regulatory Pathways for Medical Devices and Combination Products Chapter 3: Clinical Trials: GCPs, Regulations, and Compliance for Drugs, Biologics, and Medical Devices Chapter 4: FDA Communications and CDRH Meetings Chapter 5: Current Good Manufacturing Practices and Quality System Design Chapter 6: FDA User Fees Chapter 7: Regulatory Strategy Chapter 8: Medical Device Submissions Chapter 9: Medical Device Compliance and Postmarketing Activities Chapter 10: In Vitro Diagnostics Submissions and Compliance Chapter 11: Labeling, Advertising, and Promotion for Medical Devices and In Vitro Diagnostics Chapter 12: Combination Products
SECTION II: Fundamentals of EU Medical Device Regulations Chapter 1: History of EU Regulations Chapter 2: Enforcement and Competent Authorities Chapter 3: The New Medical Devices and In Vitro Diagnostic Devices Regulations Chapter 4: The European Medical Devices Legal System Chapter 5: Medical Devices: Legislation and Classification Chapter 6: In Vitro Diagnostic Medical Devices Chapter 7: General Safety and Performance Requirements and Technical Documentation: EU MDR and EU IVDR Chapter 8: Medical Device Preclinical Testing Chapter 9: Clinical Evaluation and Clinical Investigations Chapter 10: Medical Device Conformity Assessment Procedure Chapter 11: Medical Device Compliance: Postmarket Requirements Chapter 12: Medical Device National Particularities Chapter 13: Combination Products Chapter 14: Advertising and Promotion Chapter 15: Regulatory Strategys
SECTION III: Fundamentals of International Medical Device Regulations Chapter 1: Introduction to International Regulatory Affairs Chapter 2: Compliance and Enforcement Chapter 3: International Counterfeit Regulations Chapter 4: EU Pricing and Reimbursement Chapter 5: Health Technology Assessment (HTA) Chapter 6: Medical Device Premarket Requirements Chapter 7: Technical and Regulatory Requirements Chapter 8: Medical Device Quality Management Systems Chapter 9: In Vitro Diagnostic Medical Devices Chapter 10: Active Implantable Medical Devices Chapter 11: Software Chapter 12: Postmarket Requirements Chapter 13: Combination Products
In addition to a current view of regulations governing medical devices and IVDs, global experts have provided related content on combination products; regulatory strategy; advertising and promotion; enforcement and competent authorities; FDA communications, meetings, and user fees; current good manufacturing practices; quality system design; preclinical testing; clinical evaluation; and clinical investigations. This book covers the entire medical device lifecycle, from product development through postmarketing and is an excellent resource for finding answers to medical device questions and learning more about the industry.