Presented by
Management Forum
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.
29-30 Mar 2022 + 3 more dates
This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States. Participants will gain an understanding of the underlying legal and regulatory requirements and the general controls applicable to all devices, including device classification, establishment registration and device listing. With the underlying framework in mind, the approval and clearance processes for new and modified devices will be presented, including 510(k), IDE, PMA, HDE and De Novo applications. Application contents, review processes, timelines, and key guidance documents will be discussed for each major type of submission. Participants will also learn about the pre-submission process, which FDA strongly recommends
to help ensure the successful submission of novel devices.
Demonstrations of how to find key information in FDA databases will be presented using participants’ products and interests as examples. There will also be updates on recent legislation changes, new regulations and guidance documents.
Please note that while the law, regulations, principles and processes covered in the course apply to both medical devices and in-vitro-diagnostics (IVDs), the trainer’s primary experience is with medical devices.
Upon completion of this seminar, participants will:
This seminar is intended for regulatory, technical, clinical and quality professionals who require an understanding of the FDA medical device approval process. Management, legal, medical, marketing and other professionals who are interested in understanding the key principles of the medical device approval process will also benefit in attending.
History, Structure and Mission of FDA
Including how to work with FDA and pre-submissions (Q-subs)
Jonathan Hughes, Ph.D., FTOPRA, has over 32 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 specialises in regulatory strategy, regulatory and clinical development pathways, worldwide regulatory submissions and training. He has a strong knowledge of quality management systems and has direct hands-on experience of EU NB, MDSAP, US FDA, Brazilian ANVISA and Chinese NMPA inspections. He has worked with all the major international regulatory agencies, in particular (multiple) Notified Bodies and EU Competent Authorities, Japanese PMDA, US FDA, Chinese NMPA.
Jonathan has served on two European Commission Expert Working Groups on the Drug / Device Borderline and Device Classification. He is a Fellow of the regulatory professional organisation, TOPRA, and is a regular contributor on numerous educational and training programmes. Jonathan has registered teacher status at Cranfield University, is a Visiting Industrial Fellow at the University of Hertfordshire and also a visiting lecturer at University of Newcastle upon Tyne.
29-30 Mar 2022
Live online
09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 11588
Until 22 Feb
15-16 Jun 2022
Classroom
London venue TBC
09:15-17:00 UK (London)
Course code 11367
Until 11 May
12-13 Sep 2022
Live online
09:15-17:00 UK (London) (UTC+01)
10:15-18:00 Paris (UTC+02)
04:15-12:00 New York (UTC-04)
Course code 11714
Until 08 Aug
7-8 Dec 2022
Classroom
London venue TBC
09:15-17:00 UK (London)
Course code 11887
Until 02 Nov
A good and well thought out webinar with very intelligent presenter.
Sep 15 2021
Ifesinachi Onyekaba 
Research and Development Specialist, MEDTRON AG
Sep 16 2020
It was an excellent training and covers US FDA MD regulation framework. Workshops were very useful.
Ilker Yilmaz 
International Regulatory Affairs Manager, GAMA Healthcare Ltd
Sep 16 2020
Very useful overview of the FDA medical device pathways to market with valuable documentation.
Angela Sauerwald
VP Product Safety,Clinical & Regulatory Affairs at Essity, Essity - BSN medical GmbH
Mar 12 2019
I’m very pleased with the overall learning objectives, presentations and the quality of the handout given at the course. Good presentation and good focus on driving the presentations forward. A bit difficult to coordinate presentation with time table given in handouts.
Jarle Mikalsen 
CSO, Lyfstone
Mar 12 2019
The course was good and a thorough run through of the FDA approval process, with an easy to understand Mark Kramer.
Jens Johansen 
QA/RA Director, RSP Systems
Mar 12 2019
The course gives a very nice overview; especially valuable when you are just starting to considering to apply for FDA market clearance. (The speaker was) very knowledgeable about the FDA approval procedure for MDs in general. Mark is a good speaker, approachable, and he leaves plenty of room for discussion.
Ivo van Bostelen 
Project Leader, MRC-Holland BV
Oct 16 2018
I met Mark Kramer in a previous course of Combination Products. His explanations are very clear, I can perceive that he knows how FDA works, what FDA expects to get for every situation. I have enjoyed a lot and think it's been very profitable. Mark answered all our questions being pretty interactive. The course is about a general and consistent view of the FDA approval processes for medical devices, clear and comprenhensive presentation. I can sense that Mark knows very well how FDA works and what FDA expects. Very profitable and highly recommended to catch a general knowledge.
Maria Jose Hijarrubia Ibrahim 
Medical Devices Registers, Grifols S.A
Oct 16 2018
[The course] was all very good and very informative. Very informative content given by a very knowledgeable speaker on a complex area, but I now have a much better understanding of the overall submission processes.
Simon Collings
Director, IDC
Apr 17 2018
Useful and interesting course. Good amount of practical knowledge, great availability of the speaker.
Matteo Lostuzzo 
Regulatory Affairs Manager, Biotronik AG
Apr 17 2018
Excellent! Lots of Q&A, interactive session make the topic fun. Speaker has lots of experiences and strategic thinking.
Cadence Tan
Senior Regulatory Affairs Manager, GSK Consumer Healthcare
Apr 17 2018
I immensely enjoyed Mark's presentation, he is a very good speaker - conveying information in a clear and comprehensive manner, attentive, and responsive to the participants' needs.
Christina Zavadsky
QARA Manager, Zilico
Oct 16 2018
Mark was a very good speaker and it was clear from the start that he was very knowledgeable. The course was well structured, pitched at the right level for the attendees, in a clear and concise manner, with plenty of opportunity to ask questions.
Adam Williams
Senior Quality Engineer, Sharp Life Science (EU) Ltd
Apr 17 2018
It really helped me to get a sense, a meaning, to all what I do in my company in relation to US registration. I found it great to have an overview and an easy way to find the guidance documents.
Giulia Bigogno
Regulatory Affairs Specialist, Biotronik AG
Apr 27 2017
The course was very informative and Mark was very helpful with all questions we had.
Louise Bateman
Quality Manager, Bedfont Scientific Ltd
Apr 27 2017
The content was correct, the presentation was easy to follow and the speaker presented good examples.
Elvira Estape Egea
Technician Regulatory Affairs, Diagnostic Grifols S.A.
Apr 27 2017
The content was correct, the presentation was easy to follow and the speaker presented good examples.
Elvira Estape Egea
Technician Regulatory Affairs, Diagnostic Grifols S.A.
Apr 27 2017
Very clear speaking and language used. Very knowledgable.
Holly Widnall
Project Manager, Bedfont Scientific Ltd
Apr 27 2017
Great speaker, well prepared and presented.
Stephanie McGettrick
Director of RA, MedAlliance
Apr 27 2017
Money well spent
Jonathan Kearns
Human Factors Engineer, Pfizer
Apr 27 2017
Very good presentation and speaker
Jovila Dodi 
Regulatory Affairs Specialist , Tornier SAS
Apr 19 2016
This is a well run and informative course, Mark is a great presenter and reacts well to questions
Tim Allard
Regulatory Affairs, Quanta Dialysis Technologies Ltd
Apr 19 2016
Speaker is very knowledgeable. Contents are very informative and presentation was nice and clear.
Jiao Chen
Regulatory Affairs Engineer, JRI Orthopaedics Limited
Apr 19 2016
Great overview with relevant topics covered
Katie Menchi
Regulatory Affairs Manager, Sinclair Pharma Plc
Apr 19 2016
Very well presented. Course materials were good
Rob Hyson
RSB Projects Ltd
Apr 19 2016
Content was just what I needed. Very helpful.
Annette Callaghan
Managing Director, Annette Callaghan Ltd
Apr 19 2016
All excellent
Ahmed Abdullah Rajab 
Saudi Food and Drug Authority
Apr 19 2016
Informative content, nice and clear presentation, and very knowledgeable speaker
Jiao Chen
Regulatory Affairs Engineer, JRI Orthopaedics Limited
Apr 19 2016
Excellent content, presentation and speaker
Caroline Beevers
Regulatory & Risk manager, Quanta Dialysis Technologies Ltd
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