Presented by
Management Forum
FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course
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.
★★★★★ "I found the webinar to be very informative, the speaker was very experienced in the area and was cle... more"
5-6 Dec 2022 + 4 more dates
- Format: Classroom, Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
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.
Case studies will help participants to put some of the learnings into practice and to use FDA databases to research example products. The course includes up to date information which covers recent changes in legislation, regulations and guidance. Please note that the trainer has recent experience with both medical devices and in vitro diagnostics. However, please not that the course covers medical devices in general and does not provide separate sessions for specific types of medical devices (such as IVDs, software, etc).
Benefits of attending
Upon completion of this seminar, participants will:
- Understand the overall FDA medical device regulatory process
- Know what is required for 510(k), IDE, PMA, HDE and De Novo applications
- Understand how FDA processes premarket submissions
- Identify key guidance documents to help ensure a successful process
- Determine when pre-submission interaction with FDA is recommended
- Be aware of areas of change
Who should attend
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.
The FDA Approval Process for Medical Devices course will cover:
MODULE 1 – Overview of US Medical Device Regulatory Principles
Part 1 - Introduction to US FDA
History, Structure and Mission of FDA
Part 2 - Overview of US Regulatory Process and Pathway
Including how to work with FDA and pre-submissions (Q-subs)
MODULE 2 – Medical Device Definition, Classification, Device Listing & Establishment Registration
Part 1 - Medical Device Definition, Classification, Device Listing & Establishment Registration
Part 2 – Classification Case Study
MODULE 3 – Submissions
Part 1 - Pre-Market Notification 510(k)
Part 2 – De-Novo / Automatic Class III Reclassification
Part 3 - Pre-Market Approval (PMA)
Part 4 – HDE & IDE (& IUO)
Part 5 – Submission Case Study
MODULE 4 – Borderline & Combination Products
Product Designation & Combination Products
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.
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 US FDA, MDSAP, EU NB, Brazilian ANVISA and Chinese NMPA inspections. He has worked with all the major international regulatory agencies, in particular (multiple) Notified Bodies and US FDA, EU Competent Authorities, Japanese PMDA, 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.
Book FDA Approval Process for Medical Devices Classroom/Live online training
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
Please contact us for pricing if you are interested in booking 5 or more delegates
- GBP 1,299 1,499
- EUR 1,819 2,099
- USD 2,026 2,338
Until 31 Oct
- 2 days classroom-based training
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
21-24 Mar 2023
Live online
13:15-16:30 UK (London) (UTC+00)
14:15-17:30 Paris (UTC+01)
09:15-12:30 New York (UTC-04)
Course code 12519
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 14 Feb
- 4 sessions of live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
21-22 Jun 2023
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 12718
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 17 May
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
- GBP 1,299 1,499
- EUR 1,869 2,149
- USD 2,137 2,449
Until 14 Aug
- 2 days classroom-based training
- Meet presenters and fellow attendees in person
- Lunch and refreshments provided
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
4-5 Dec 2023
Live online
09:15-17:00 UK (London) (UTC+00)
10:15-18:00 Paris (UTC+01)
04:15-12:00 New York (UTC-05)
Course code 12301
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 30 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Reviews of IPI's FDA Approval Process for Medical Devices training course
I found the webinar to be very informative, the speaker was very experienced in the area and was clearly an SME.
Jun 22 2022
Liam O'Malley 
R&D Project Manager, Teva Pharmaceuticals Runcorn
Jun 22 2022
I think it was great, a lot of helpful materials.
Tyler Beaverson 
Technical Advisor, NAMSA
Mar 23 2022
Absolutely fantastic. I needed to be able to communicate more effectively with my Regulatory colleagues and I believe the information I have learned on this course will assist me to do that
Jenny Ramsey
Quality Engineer - Compliance, Pfizer R&D UK Ltd
Jun 22 2022
Jonathan was very knowledgeable and experienced in the industry, he took the time to answer questions from the participants thoroughly.
Sophie Edmonds-Allen
R&D Senior Scientist Human Factors, Teva Pharmaceuticals Runcorn
Mar 23 2022
[Jonathan was] very detailed and patient
Kavi Sharma
Clinical Project Manager, Ultromics Ltd
Mar 23 2022
Very detailed and patient
Kavi Sharma
Clinical Project Manager, Ultromics Ltd
Mar 23 2022
I was happy to attend to this webinar and it was really useful and well-explained and organized.
Mireia Crosa 
Regulatory and Compliance Specialist, Diagnostic Grifols, S.A.
Mar 23 2022
I was hoping to get more information regarding 510(k) submissions. I am very happy that I got the opportunity to learn much more. I learned a lot and feel more confident about my understanding of the submission processes.
Natale Rolim 
Project Manager, EpiGuard
Mar 23 2022
All was great, no complaints!
Angelica Morreno
Regulatory Affairs Assistant, Sinclair Pharmaceuticals
Sep 15 2021
A good and well thought out webinar with very intelligent presenter.
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 ltd
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
United Kingdom
- 3M Healthcare Ltd
- 42 Technology Ltd
- Acrobot Company Ltd
- Alere Technologies AS
- Allergan Limited
- Annette Callaghan Ltd
- Arakis Ltd
- Bedfont Scientific Ltd
- Bespak Europe Ltd
- Bibra Toxicology Advice & Consulting
- Biogen Idec Ltd
- Bioquell UK Ltd
- Britannia Pharmaceuticals Ltd
- CAMBRIDGE BIOSTABILITY
- Cambridge Design Partnership
- Carl Zeiss Meditec
- ConvaTec Ltd
- ConvaTec UK Ltd
- Corin Group Plc
- Covidien (UK) Commerical Limited
- COZART
- DCA Design International
- Depuy CMW
- DePuy International Limited
- Ethicon, Division of Johnson & Johnson Medical
- GAMA Healthcare Ltd
- GBUK Limited
- Glysure Limited
- GSK Consumer Healthcare
- Huntleigh Technology Limited
- Hyaltech Ltd.
- IDC ltd
- Imperial College London
- Industrial Design Consultancy Limited
- Informa Healthcare Limited
- Intelligent Ultrasound
- Isotron Ltd
- JOHNSON & JOHNSON
- Johnson & Johnson Medical Ltd
- JRI Orthopaedics Limited
- KCI UK Holdings Ltd
- Lifescan Scotland Ltd
- MAGSTIM CO LTD
- Magstim Company Ltd
- MedAlliance
- Medicines and Healthcare Products Regulatory Agency (MHRA)
- Mediqol Limited
- Medtrade Products Ltd
- Microvisk Technologies
- NGPOD
- Nobel Biocare
- Norgine Limited
- Olympus KeyMed Ltd
- Optos plc
- Ortho-Clinical Diagnostics (Johnson & Johnson)
- OrthoMimetics Ltd
- OrthoSon
- Orthoson Ltd.
- Owen Mumford Ltd
- PA Consluting
- PA Consulting
- PA Consulting Group
- Pan Medical Ltd
- PEARSALLS LTD
- Pfizer
- Pfizer R&D UK Ltd
- Probus Regulatory Services Ltd
- Quanta Dialysis Technologies Ltd
- Reckitt Benckiser
- Reckitt Benckiser Healthcare (UK) Ltd
- Renishaw plc
- RSB Projects Ltd
- Russell Square Quality Associates Limited
- Sagentia Limited
- Sanguin International
- Sauflon Pharmaceuticals Ltd
- SGR Consulting Services Ltd
- Sharp Life Science (EU) Ltd
- Sinclair Pharma
- Sinclair Pharma Plc
- Sinclair Pharmaceuticals
- Smith & Nephew Wound Management
- Smiths Medical International Ltd
- Speciality Fibres and Materials Limited
- Sphere Medical Ltd
- Stanmore Implants Worldwide Limited
- Technology Partnership Plc
- Teva Pharmaceuticals Runcorn
- Tissue Science Laboratories PLC
- Ultromics Ltd
- UNIVERSITY OF BRISTOL
- University of Manchester Intellectual Property Ltd
- Unomedical Ltd
- VASCUTEK LTD
- Vectura Group plc
- Wesley Coe Limited
- Xiros
- XIROS PLC
- Zilico
Germany
- Abbott GmbH & Co. KG
- Abbott Products GmbH
- Acandis GmbH
- Boehringer Ingelheim Pharma GmbH & Co KG
- Carl Zeiss AG
- Dr Suwelack Nachf Gmbh & Co KG
- Essity - BSN medical GmbH
- HEXAL
- ING. ERICH PFEIFFER GmbH
- MEDTRON AG
- Miltenyi Biotec GmbH
- Olympus Surgical Technologies Europe
- Pfenning Meinig & Partner
- Roche Diabetes Care GmbH
- Roche Diagnostics GmbH
- Sanofi-Aventis Deutschland GmbH
- Siemens AG
- Siemens Healthcare GmbH
- Stryker Leibinger GmbH & Co Kg
Ireland
- ABBOTT IRELAND
- Aerogen Ltd
- Boston Scientific
- Boston Scientific Ireland Ltd
- Cook Ireland Ltd
- ELAN PHARMA TECHNOLOGIE
- Henkel Ireland Limited
- INAMED AESTHETICS
- Medtronic Ireland
- Merit Medical
- RESPIRONICS (IRELAND) LTD
- SWORDS LABORATORIES LTD
- Tech Group Europe
Switzerland
- Bayer Consumer Health Devision
- Biotronik AG
- Celgene International Sarl
- DSM Nutritional Products Ltd Branch Pentapharm
- Imtool Sarl
- Institut Straumann AG
- ISS AG, Integrated Scientific Services
- Medtronic International Trading Sarl
- Nobel Biocare
- Nobel Biocare AB
- Novartis Vaccines & Diagnostics AG
- Rising Tide
- ZIMMER GMBH
Denmark
- Engineers & Doctor As
- Ferring Pharmaceuticals A/S
- FERROSAN A/S
- LAB Research (Scantox)
- Leo Pharma A/S
- Neurodan A/S
- Novo Nordisk A/S
- RSP Systems
- RSP Systems A/S
- Unomedical A/S
- William Cook Europe ApS
France
- Air Liquide Santé International
- Becton Dickinson
- Biosphere Medical SA
- Boston Scientific Corp
- Cabinet Michel Richebourg
- CyberConseil
- Galderma R&D
- Guerbet
- Sanofi-Aventis Groupe
- Sanofi-Aventis R&D
- Tornier SAS
Sweden
- AstraZeneca AB
- Baxter
- BONESUPPORT AB
- DENTSPLY Implants
- Euro Diagnostica AB
- Glycorex Transplantation AB
- HemoCue AB
- Mölnlycke Health Care AB
- Q-Med AB
- Wellspect Healthcare
- XVIVO Perfusion AB
Italy
- Diasorin S.p.A
- Digitec S.r.l.
- Eurofins Biolab Srl
- Invatec SRL
- Orthofix Srl
- Sigea Srl
- Sorin Group Italia srl
Netherlands
- Aqtis Medical
- Biotop Medical
- Merck Sharp & Dohme
- MRC-Holland BV
- Philips Consumer Lifestyle
- POLYGANICS BV
Spain
- Diagnostic Grifols S.A.
- Diagnostic Grifols SA
- Diagnostic Grifols, S.A.
- Grifols S.A
- Grifols S.A.
Belgium
- Fujirebio-Europe NV
- IBA
- Janssen Pharmaceutica NV
- Oystershell NV
Austria
- Baxter Innovations GmbH
- MED-EL Medical Electronics
- PRO-MED AG
Finland
- Medix Biochemica
- Orion Pharma
- WALLAC OY
Saudi Arabia
- Gulf Health Council
- SAUDI FOOD & DRUG AUTHORITY
- Saudi Food and Drug Authority
United States of America
- ARROW INTERNATIONAL INC
- NAMSA
- North American Science Associates
Czech Republic
- Contipro Pharma as
- Teleflex Medical
Norway
- EpiGuard
- Lyfstone
Poland
- LiNA Medical Polska Sp. z o.o.
- LiNA Medical Sp. z o.o.
India
- QUINTILES RESEARCH (INDIA) PRIVATE
Japan
- Jimro Co Ltd
Russia
- CWT Russ LLC
Turkey
- NEMED Tibbi Urunler
Run FDA Approval Process for Medical Devices Classroom/Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements:
