Presented by
Management Forum
Advanced Regulatory Affairs for Medical Devices Training Course
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
★★★★★ "Everything good. Even though all different countries' people took this course, but the speakers cons... more"
9-10 October 2023
+ 1-2 February 2024, 4-7 June 2024, 7-8 October 2024
from £1099
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
The regulatory environment for medical devices is in a transitional period. With the increased focus on patient safety, the MDR has introduced many changes to the requirements and processes involved.
Designed for professionals with a working knowledge of medical device regulatory affairs, this course will provide essential guidance on how to successfully transfer products from the current regulatory system under the Medical Device Directive (MDD) to the new MDR. Regulatory strategy and life cycle management will be a key focus of the programme with comprehensive sessions
on regulatory pathways, technical documentation, clinical evaluations and investigations. There will also be a review of the requirements for the vigilance system, post-market surveillance (PMS) and post-market clinical follow-up (PMCF) studies.
Delegates will cement the knowledge gained through case studies and practical workshops and there will be ample opportunity to discuss the complexities involved with two medical device experts, both of whom have huge knowledge and experience in this field.
This event would be an excellent follow-on course from our three-day programme An Introduction to the Medical Device Regulation.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Who should attend?
This course will provide experienced medical device professionals with the practical regulatory knowledge to apply life cycle management in an MDR environment, particularly those who play a key role in transitioning their products to the MDR.
- Medical device regulatory affairs professionals
- Vigilance and PMS managers
- Clinical evaluation/investigation specialists
- Project managers
The Advanced Regulatory Affairs for Medical Devices course will cover:
The impact of the MDR on your role and responsibility
- Why a change in regulation?
- Structure of the new Regulation and flow of compliance
- Key analysis of the changes
- Changes to roles and responsibilities of key stakeholders
- Competent authorities and Notified Bodies
- Economic operators – role and responsibilities
- Person responsible for regulatory compliance
Borderlines and classification
- Borderline determination
- Software qualification and classification
- Understanding the classification process
- Investigating the classification rules (emphasis on the new rules)
Classification workshop: Practical session on applying the new rules
GSPRs Annex I Requirements
Requirements for clinical evaluations and investigations
- Requirements, standards and guidance
- Understanding the importance of clinical evaluation
- Key requirements of clinical investigations
Clinical evaluation and investigation workshop: Consolidating the key requirements
Conformity assessment
- Various conformity assessment routes
- Scrutiny process and key considerations
- Selection of and engagement with your Notified Body
The new market surveillance tools
- The European database (EUDAMED)
- Unique device identification (UDI)
- Supply chain surveillance and traceability
Requirements for PMS
- Understanding PMS requirements
- Implementing effective PMS
The new vigilance system
- Management of adverse incidents
- Definitions: what is reportable, the reporting process and investigation
- Corrective action
- Periodic safety update reports – how to manage this requirement
Vigilance workshop: Report or not to report?
PMCF studies
- Requirements for PMCF
- Types of PMCF
Future Evolution of the Medical Device Legislation
- UKCA Marking
Theresa Jeary
Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.
She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.
Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.
Janette Benaddi
Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.
She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.
Book Advanced Regulatory Affairs for Medical Devices 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
9-10 October 2023
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12710
- GBP 1,299
- EUR 1,896
- USD 2,129
- 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
1-2 February 2024
Live online
09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 13506
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 28 Dec
- 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
4-7 June 2024
Live online
13:30-17:15 UK (London) (UTC+01)
14:30-18:15 Paris (UTC+02)
08:30-12:15 New York (UTC-04)
Course code 13722
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 30 Apr
- 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
7-8 October 2024
Live online
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13963
- GBP 1,099 1,299
- EUR 1,616 1,896
- USD 1,817 2,129
Until 02 Sep
- 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 Advanced Regulatory Affairs for Medical Devices training course
Everything good. Even though all different countries' people took this course, but the speakers considered many details for them until end of course. I am really thankful that you gave us opportunities to have much time and appreciated with you.
Sep 27 2022
Heejun Hong 
Student, Dongguk University, Republic of Korea
Sep 27 2022
[I liked] the speed, the content. The workshops: had some nice discussion in the breakout room with participants that joined with a microphone (and camara). Clarification on PMCF.
Jennie Mettivier Meijer 
Project Manager Medical Devices & Quality Systems, BioTop Medical
Sep 27 2022
Both speakers are excellent communicators and pleasant persons. Slides were clear.
Teresa Lopes
Manager Medical Devices, BioTop Medical
Sep 27 2022
I less like working in groups and more prefer presentations and detailed explanation of all the exercises by the speakers. Very good webinar!
Elen Lasri 
RA specialist, Elcam Medical Acal Ltd
Sep 27 2022
I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.
Lim KyoungYoon
Smart Life Care Solution Laboratory, Dongguk Univ
Sep 27 2022
I had fun in the classification part, and I was interested in classifying medical devices in a different way than in Korea.
Lim KyoungYoon
Smart Life Care Solution Laboratory, Dongguk Univ
Apr 20 2021
This webinar met all my expectations. The content and presentations was very interesting and the speakers were great.
Sophie Lamaison 
Blue Reg
Apr 20 2021
The content was very good, the presentation was clear and the speakers were didactic
Gabriela Rodrigues
Regulatory Affairs Specialist, DKT Woman Care
United Kingdom
- Blue Reg Pharma
- CooperVision Manufacturing Ltd
- Corin Limited
- Kyowa Kirin International
- N/A
- Pennine Healthcare Ltd
- Presspart
- Vectura Ltd
France
- Blue Reg
- DKT Woman Care
- Oticon Medical
Korea, Republic Of
- Dongguk Univ
- Dongguk University
- Dongguk University, Republic of Korea
Netherlands
- BioTop Medical
- Veeva Systems
Greece
- Pharmathen
Israel
- Elcam Medical Acal Ltd
Run Advanced Regulatory Affairs for Medical Devices 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 experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
