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US Regulatory Affairs for Medical Devices

Gain the skills needed to navigate the US medical devices market

27 - 28 November 2019

Radisson Blu Edwardian Grafton, London

The US is a huge market for medical devices, yet there are a number of key differences between FDA procedures and those in Europe.

This essential course will provide you with a comprehensive foundation in US regulatory affairs to make your submission a success. Over two days, delegates will gain a solid understanding of regulatory standards, requirements and submission options and processes, including current hot topics such as software as a medical device.

Delegates will be able to cement this knowledge through interactive workshops.

  • Understand the scope of FDA regulation
  • Consider the possible approval routes
  • Investigate how devices are reviewed by the FDA
  • Examine labelling and UDI requirements
  • Prepare for inspections
  • Learn where to find the information you need


 Jonathan Hughes

Jonathan has 30 years of worldwide regulatory and clinical affairs experience across medical devices, combination products, diagnostics and human/veterinary pharmaceuticals. 

Following completion of his PhD in veterinary pathophysiology, Jonathan began his career in regulatory affairs at A H Robins. He subsequently held regulatory affairs positions in drug and device companies, including Smith & Nephew, Glaxo, Bristol-Myers Squibb and ConvaTec. Jonathan has served on two European Commission Expert Working Groups on the Drug/Device Borderline and Device Classification. Jonathan now runs his own consulting firm, JHRA, specialising in medical device and combination product regulatory affairs. He has extensive experience with global regulatory affairs, including the US FDA, Japanese PMDA and Chinese FDA.

Jonathan has substantial training and educational experience, delivering lectures for two medical technology MSc courses (at the University of Hertfordshire and Cranfield University) and a biomedical science MSc course with Newcastle University.

  • Regulatory Affairs professionals with previous experience in medical devices, but who may be unfamiliar with the US market
  • Those moving into Regulatory Affairs from other areas within a medical device company  (Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on US regulatory affairs for medical devices

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