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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Chapter 1: Global Regulatory Initiatives
Chapter 2: Regulations, Pediatric Study Plan, and Product Development—US
Chapter 3: Rare Diseases—US
Chapter 4: Medical Device Development—US
Chapter 5: Drug Regulations—Canada
Chapter 6: Regulatory Initiatives—Latin America and the Caribbean
Chapter 7: Paediatric Regulation and the Paediatric Investigation Plan—EU
Chapter 8: Regulatory Requirements—UK
Chapter 9: Regulatory Requirements—Switzerland
Chapter 10: Drug Development—Japan
Chapter 11: Regulations—Australia and New Zealand
Chapter 12: Regulations—China
Chapter 13: Drug Development—India
Chapter 14: Drug and Device Requirements—Rest of the World (RoW)