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: 18-19 May 2023 Live online
  • Also: 15-16 Nov 2023 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
  • Presented by Dr Jonathan Hughes
  • Next: 21-24 Mar 2023 Live online
  • Also: 21-22 Jun 2023 Live online
  • Also: 18-19 Sep 2023 Classroom
  • Also: 4-5 Dec 2023 Live online

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
  • Presented by Dr Jonathan Hughes