Presented by
Management Forum
Advanced Regulatory Affairs for Medical Devices In-house Training
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
★★★★★ "I thought it covered a vast area in great detail and was evenly paced. Both speakers were excellent... more (9)"
- Format: Live online
- CPD: 12 hours for your records
- Certificate of completion
Course overview
Explore the MDR's updates enhancing patient safety and understand its revised requirements and processes to navigate the evolving regulatory environment effectively.
This course is crucial for professionals already versed in medical device regulatory affairs, offering indispensable guidance on transitioning products from the current Medical Device Directive (MDD) framework to the new Medical Device Regulation (MDR).
Emphasizing regulatory strategy and lifecycle management, the program includes in-depth sessions on regulatory pathways, technical documentation, clinical evaluations, and investigations. Participants will also delve into requirements for the vigilance system, post-market surveillance (PMS), and post-market clinical follow-up (PMCF) studies.
Through interactive case studies and practical workshops, delegates will solidify their knowledge and engage in discussions with two experienced medical device experts, navigating the complexities of regulatory compliance effectively.
This course serves as an ideal continuation from our comprehensive three-day program, An Introduction to the Medical Device Regulation, offering advanced insights and practical skills essential for regulatory professionals in the evolving medical device landscape.
This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.
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, including:
- Medical device regulatory affairs professionals
- Vigilance and PMS managers
- Clinical evaluation/investigation specialists
- Project managers
This 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
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.
Theresa Jeary
BSI
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.
Reviews of IPI's Advanced Regulatory Affairs for Medical Devices training course
I thought it covered a vast area in great detail and was evenly paced. Both speakers were excellent and extremely helpful during question time
Oct 9 2023
Andrea Beasley 
Senior Manager, Global Trade Compliance and Logistics, CooperVision Manufacturing Ltd
Sep 27 2022
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.
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
- MD Compliance Ltd
- 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
Iceland
- Nox Medical
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, based on 10 attendees
- 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:
