This essential course will provide you with a comprehensive foundation in US regulatory affairs for medical devices. Over two days, delegates will gain a solid understanding of regulatory standards, requirements and submission options and processes. Delegates will be able to cement this knowledge through interactive exercises and case studies.
• Understand the scope of FDA regulation
• Consider the possible approval routes
• Understand what is required in the electronic technical dossier
• Investigate how devices are reviewed by the FDA
• Examine labelling and UDI requirements
• Discuss practical considerations for operating in the US
• Comprehend quality management and manufacturing standards
• Prepare for audits and inspections
• Reflect on post market surveillance requirements
Kathleen runs her own consultancy, 2Harris Consulting, specialising in global regulatory strategy and quality compliance for medical devices, pharmaceuticals, clinical trial designs and regulatory due diligence for mergers and acquisitions. In previous roles, Kathleen was responsible for for implementing global RA/QA strategy in a Class III IVD/medical device business, has built strategic partnerships with government agencies, including the FDA, Health Canada and regulatory agencies in Latin America and has acted as a VP for regulatory affairs in the Americas. Kathleen began her career working in regulatory quality for the FDA in Indiana.