Jonathan Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 35 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro diagnostics. He has worked with medical device and pharmaceutical companies, both large and small, across multiple locations to help develop and execute regulatory strategies for market clearance, approval and access.

Jonathan has hands-on experience in a variety of therapeutic areas and has worked across different technologies and types of medical products including medicated devices (devices containing ancillary drug and biologic constituents), drug delivery systems and componentry, sterile and non-sterile disposables and durable equipment, in-vitro diagnostics, software controlled devices and standalone software (including mobile apps). He has experience of regulating medical devices and combination products across most international markets including the European Union, US, Japan, China, Canada and Australia.

  • Next: 15-16 Nov 2023 Live online
  • Also: 14-15 Feb 2024 Live online
  • Also: 17-18 Oct 2024 Live online

Drug/Device and Device/Drug Combinations in the EU and USA

Live online

Practical guidance on borderline Issues and combination products

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes
  • Next: 27-28 Nov 2023 Live online
  • Also: 19-22 Mar 2024 Live online
  • Also: 19-20 Jun 2024 Live online
  • + 2 more

FDA Approval Process for Medical Devices

Live online, Classroom

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

  • 12 CPD hours Focused
  • Presented by Dr Jonathan Hughes