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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 the largest market in the world for medical devices and in 2018 it represented around 40% of the medical device market globally. The regulatory framework consists of stringent requirements for manufacturers and in there are several significant differences between FDA procedures and those in Europe.

This essential course will provide you with a comprehensive foundation in US regulatory affairs to guarantee your compliance with such stringent requirements, ensuring your submissions are a success.

Over two days, delegates will gain a solid understanding of regulatory standards, requirements, submission options and processes, including current hot topics such as software as a medical device and the harmonisation of ISO 13485 and the Medical Device Single Audit Programme (MDSAP).

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

  • Understand the scope of FDA regulation and compare it to the European regulatory landscape
  • Consider the possible approval routes and find the best fit for your device
  • Familiarise yourself with and confidently navigate through the FDA approval process
  • Examine labelling and UDI requirements for your device
  • Learn how to confidently prepare for inspections
  • Understand the latest US regulatory updates, including the harmonisation of ISO 13485 and the MDSAP

 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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