Meet...

Jonathan Hughes

Presenter

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.

Jonathan Hughes’s courses

  • 02 Dec • 2 day course

FDA Approval Process for Medical Devices

Live online

Reviews for Jonathan ’s courses

That was perfect, thank you! The presentation, content and presenter were very good. I hoped to get basic understanding of the FDA submission pathways and this is certainly achieved! Overall, I am very satisfied having followed the course.

31 Mar 2025

FDA Approval Process for Medical Devices

The training materials were well prepared and of high quality. These will be an excellent reference when we want to start planning device registrations for US market. Overall, very happy with the content, speaker and presented materials.

31 Mar 2025

FDA Approval Process for Medical Devices

The process was well thought out. I would recommend.

2 Dec 2024

FDA Approval Process for Medical Devices

I got useful information.

10 Sep 2024

FDA Approval Process for Medical Devices

He's a real guru and he's also a very good teacher.

10 Sep 2024

FDA Approval Process for Medical Devices

Excellent conference, speaker, material etc were perfectly balanced and understandable.

10 Sep 2024

FDA Approval Process for Medical Devices

This course is very informative and interactive and touched all aspects off Medical device approval process by FDA. Overall excellent, webinar logistics are surprisingly easy, Jonathan's presentation of FDA content is exemplary. Jonathan is a great educator and shared all his experiences.

18 Jun 2024

FDA Approval Process for Medical Devices

Jonathan was a really good speaker and took his time to answer any of our questions. He was very knowledgeable.

18 Jun 2024

FDA Approval Process for Medical Devices

Jonathan was really very excellent.
Clearly has a thorough understanding of the FDA and is able to impart that knowledge incredibly well.
The slides were extensive (Jonathan clearly put a lot of time and effort into these) and will be a great resource for me in the future.

18 Jun 2024

FDA Approval Process for Medical Devices

I think Jonathan was really knowledgeable and had an easy way to explain things. Very graceful and humble teacher, including everyone and making all feel ok to ask questions.

18 Jun 2024

FDA Approval Process for Medical Devices