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.
31 Mar-1 Apr 2020
& 22-23 Sep 2020
GBP 1,499 1,299 *
EUR 2,099 1,819 *
USD 2,338 2,026 *
* When you book before 24 Jan
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.
Overview of US Medical Device Regulatory Principles
Pre-Submissions
510(k) process (Premarket Notification)
De Novo Applications for Low-Moderate Risk Devices
Investigational Device Exemption (IDE) for Clinical Investigations
Premarket Approval (PMA) for Class III Devices
Humanitarian Device Exemptions
Mark Kramer
Dr Mark Kramer, RAC, is President, Regulatory Strategies, Inc., a regulatory consultancy specializing in medical devices and combination products. He has more than 25 years’ experience in regulatory affairs, including 17 years at the US Food and Drug Administration culminating in his position as Director of FDA’s Office of Combination Products from 2002 to 2007. From 2007-2010, he was Vice President, Regulatory Affairs and Chief Regulatory Strategist at GE Healthcare, where he had executive responsibility for US, Canadian and Latin American regulatory affairs for the medical device business.
He is on the Board of Directors of the Regulatory Affairs Professional Society (RAPS), served as Chair of the Wisconsin RAPS Chapter from 2007-2010, and is an adjunct faculty member for St. Cloud State University’s Master’s program in regulatory affairs.
| 31 Mar-1 Apr 2020 | ||||
| 31 Mar-1 Apr 2020 | Cavendish Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
GBP 1,299.00 EUR 1,819.00 USD 2,026.00 Until 24 Jan* |
Enrol now |
| 22-23 Sep 2020 | ||||
| 22-23 Sep 2020 | Rembrandt Hotel, London | GBP 1,499.00 EUR 2,099.00 USD 2,338.00 + VAT @ 20.00% |
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register. | |
* Note the early booking discount cannot be combined with any other offers or promotional code
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“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
“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
“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
“[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
“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
“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
“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
“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
“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
“Useful and interesting course. Good amount of practical knowledge, great availability of the speaker. ”
Matteo Lostuzzo, Regulatory Affairs Manager, Biotronik AG
“Very clear speaking and language used. Very knowledgable. ”
Holly Widnall, Project Manager, Bedfont Scientific Ltd
“Money well spent”
Jonathan Kearns, Human Factors Engineer, Pfizer
“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.
“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.
“Great speaker, well prepared and presented. ”
Stephanie McGettrick, Director of RA, MedAlliance
“Very good presentation and speaker ”
Jovila Dodi, Regulatory Affairs Specialist , Tornier SAS
“The course was very informative and Mark was very helpful with all questions we had. ”
Louise Bateman, Quality Manager, Bedfont Scientific Ltd
“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
“All excellent ”
Ahmed Abdullah Rajab, Saudi Food and Drug Authority
“Excellent content, presentation and speaker ”
Caroline Beevers, Regulatory & Risk manager, Quanta Dialysis Technologies Ltd
“Informative content, nice and clear presentation, and very knowledgeable speaker”
Jiao Chen, Regulatory Affairs Engineer, JRI Orthopaedics Limited
“Content was just what I needed. Very helpful. ”
Annette Callaghan, Managing Director, Annette Callaghan Ltd
“Very well presented. Course materials were good”
Rob Hyson, RSB Projects Ltd
“Speaker is very knowledgeable. Contents are very informative and presentation was nice and clear. ”
Jiao Chen, Regulatory Affairs Engineer, JRI Orthopaedics Limited
“Great overview with relevant topics covered ”
Katie Menchi, Regulatory Affairs Manager, Sinclair Pharma Plc