Presented by
Management Forum
The Medical Device School - From Concept to CE Marking In-house Training
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.
★★★★★ "Very good, I achieved what I set out to do at the beginning of the week."
- Format: Live online, Classroom
- CPD: 30 hours for your records
- Certificate of completion
Course overview
Bringing a medical device to the marketplace is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to successful market placement comes from many different skilled individuals and organisations who should be aware of all the stages involved and be able to relate their responsibilities to the needs of other professionals, scientists, clinicians and regulatory and quality experts.
This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process. The programme will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, practical workshops and case studies covering each process applicable to device development, marketing and, eventually, postmarket procedures. There will be ample time throughout the five days for informal discussions
with our expert faculty and fellow professionals.
Benefits of attending:
Understand the procedures for taking a medical device to the marketplace- Learn what regulations control the manufacture and marketing of devices in the EU
- Ensure compliance with the MDR
- Gain an insight into different aspects of the process for obtaining the CE mark for a device
- Discover a holistic approach to device development and marketing
- Participate in workshops and learn from other people’s experiences
- Understand how other professionals affect the process for bringing a device to market
- Network with participants from organisations similar to your own
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 event has been designed primarily for those who wish to understand the processes involved in bringing a medical device to market. General medical devices as well as active implantable, in-vitro diagnostic and drug device products will be covered in the programme.
The course will be of particular interest to those seeking to introduce new medical devices to the market. Previous delegates who have benefited include regulatory, quality, clinical and marketing managers.
This course will cover:
Day One
What is a Medical Device?
- Definitions and examples
Device Design and Development
- Overview
- Device innovation
- How is a device developed from concept?
- From idea to market, the overall steps
What Regulations Control the Manufacture and Marketing of Devices in the EU?
- A brief history of the Medical Device Directives explained (AIMDD, MDD and IVDD)
- An overview of the Medical Device Regulations 2017/745
How Does a Device obtain a CE Mark?
- What does the CE Mark mean?
- Overview of the CE Mark process for a device
- Device classification
UKCA
Economic Operators, Competent Authorities and Notified Bodies
- Who are economic operators and what are their responsibilities?
- What is a competent authority?
- The role and responsibility of a competent authority
- What is a Notified Body?
- The role and responsibility of a Notified Body
- Relationships with manufacturers
Classification of Medical Devices
- How do you classify a medical device?
Classification workshop with case studies
Day Two
Risk Analysis and Risk Management
- Review of ISO EN 14971:2007, ‘Medical Devices Application of Risk Management to Medical Devices’
- What procedures must a manufacturer follow?
How Should a Risk Analysis be Conducted? – Risk Analysis Workshop
Biological Evaluation of Medical Devices
- ISO 10993 and the biological safety assessment process
- Where product safety assessment fits in New Product Development
Technical Files and Design Dossiers
- What are these documents?
- What should they contain and how should they be presented?
Quality Systems for Medical Devices
- What is a Quality System?
- What do manufacturers need to do to implement a Quality System?
- What are the regulations and guidelines for Quality Systems?
Labelling and Packaging of Devices
- What information needs to be provided and how should it be set out?
- What regulations and guidelines should be followed?
Day Three
Regulations and Guidelines Applicable to Medical Device Studies
- Review of ISO 14155 and other available guidelines
Clinical Evaluations
- How to conduct clinical evaluations
- Controls of the clinical evaluation plan and clinical evaluation report
- Literature search
Conducting Medical Device Clinical Investigations
- How to conduct medical device clinical investigations
- Study design
- Study content
Documents Necessary for Medical Device Clinical Investigations
- Clinical investigation plan
- Clinical investigation report
Clinical Investigation/Evaluation Workshop
Approvals for Conducting Clinical Studies
- Documents required
- Ethics committees
- Competent authorities
Day Four
Software and Medical Devices
- Understanding the requirements for medical device software
- Software qualification and classification
- Clinical evidence for medical device software
- Additional considerations for Artificial Intelligence
In-Vitro Diagnostic Products
- The IVD Directive
- New IVD Regulation (2017/746)
- Transition period preparation
- Impact on compliance and risk analysis
Making Sense of the European Reimbursement Environment
- Making sense of reimbursement, regulation and market access
- Understanding different approaches adopted to the reimbursement of medical devices
- Implications for manufacturers of medical devices
Drug/Device Products
- Regulations for demarcation of medicinal products and devices
- Exploration of borderline issues
- Quality considerations
Devices Incorporating Materials of Animal Origin
- What’s the risk?
- Specific standards on animal materials
- Conformity assessment for devices containing animal-derived materials
Day Five
Post-market surveillance (PMS)
- What constitutes PMS? The basic principles
- The regulatory requirements for PMS
- The increasing importance of PMS
- A review of available guidelines for PMS
EC Medical Device Vigilance
- Basic principles
- Reporting arrangements
- Role of manufacturer, competent authority and Notified Body
- Review of the available guidelines for device vigilance
Workshop with case studies
Paula Wittels
Translucency Ltd
Key positions held in career
Programme Director Translucency Ltd
Director of Operations Quintiles Consulting, specialising in medical device reimbursement
Marketing Director Howmedica International (at the time a Pfizer company) manufacturing orthopaedic implants
Group Product Manager Amersham International (now part of GE healthcare). Launch of novel IVD platform
Major areas of expertise
Experience across a wide range of medical technologies
Business planning
Market assessment
Product management
Services offered through Translucency
Early commercialisation
Market access
Product reimbursement
Management of multi-country projects
Educational and professional achievements
PhD in Public Health
MA in Natural Sciences (specialist subject biochemistry)
MSc in Information Science
Member of the Chartered Institute of Marketing
Speaker on medical device reimbursement at conferences
Theresa Jeary
BSI
Theresa works for SFL as Head of Combination Products. 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 a part of the team for many commercially available medicinal and medical device products.
Zuzanna Kwade
Dedalus Healthcare
Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.
Adrian Keene
NAMSA
Adrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was previously Head of Notified Body for the UK Notified Body SGS. Prior to that he was Global Clinical Affairs and Regulatory Manager for Medical Devices, with responsibility for conformity assessment activities of high risk (class III) devices under the Medical Devices Directive.
In this role he combines his experience from new product development with EU regulatory requirements to provide a balanced interpretation of the needs and expectations of both competent authorities and manufacturers. He works with a broad range of devices including drug-device combination products.
Adrian has 25 years experience in the medical device industry, and previously held the role of Technical Manager – Medical Devices at the Notified Body LRQA. Prior to that he worked in the medical device industry, latterly as Global Product Safety Manager at Smith and Nephew. Here he created a highly effective team delivering product safety and risk management to Smith and Nephew’s global wound management portfolio. His team was responsible for providing toxicological and risk management strategies to expedite product launches, commercialisation, and post market activities, including Far Eastern markets (Japan and Korea).
He joined Smith & Nephew directly from The School of Pharmacy (University of London) following postgraduate research in retinoid-induced skeletal toxicity and an honours degree in Toxicology and Pharmacology. He also holds a Diploma in Managing Medical Product Innovation from the Scandinavian International Management Institute.
Adrian is a UK expert for ISO/TC 194 (Biological Evaluation of Medical Devices), and has been an active participant in NB-MED and NBRG.
Will Burton
Russell Square Quality Associates Limited
Will is currently the Director of Russell Square Quality Representatives (RSQR) Ltd. He is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA).
David Howlett
Pharma Delivery Solutions
In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has led to involvement in projects with focus in pulmonary, nasal and other delivery routes, with an international client base. Much of the activity of PharmaDelivery Solutions Ltd is focused in the area of development programme support, regulatory GAP analysis and generation of documentation supporting development and test programmes, together with data review and contingency evaluation.
David has over 35 years experience in the development, industrialization and approval of inhalation drug delivery systems, combination products and medical devices.
Stuart Angell
Ivdeology
Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition to the new IVD/Medical Device Regulations, MDSAP and ISO13485:2016.
He has over 15 years in the IVD industry and in previous roles has been responsible for designing, reviewing and maintaining regulatory frameworks for self-declared and annex list II products including technical documentation for EU and global submissions (FDA, Health Canada, TGA, Russia, Latin America). He has an excellent understanding of risk management, Post Market Surveillance (PMS) and vigilance.
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.
Reviews of IPI's The Medical Device School - From Concept to CE Marking training course
Very good, I achieved what I set out to do at the beginning of the week.
Jun 12 2023
Natasha Smith 
Marketing Director, Bedfont Scientific Ltd
Jun 12 2023
Really engaging and focused on the EU. Enjoyed the fact this was current and mentioned up to date legislation and regulation updates.
Chelsey Ludlow
Regulatory Affairs Coordinator, Vision RT Ltd
Jun 12 2023
Speaker are very good and expert in their area
Lutfhi Zarkasyi 
Plant Head, PT. Forsta Kalmedic Global
Jun 12 2023
I really enjoyed the workshops as it gave the opportunity to interact with the other delegates on the course and discuss and develop learnings from the presentations.
Emma Hickson
Research Advisor, Convatec
Jun 12 2023
excellent
Lutfhi Zarkasyi
Plant Head, PT. Forsta Kalmedic Global
Jun 12 2023
I particularly enjoyed the break out rooms as this gave you time to have discussions with other attendees and it broke up the presentations which aided concentration.
Samantha Hutchinson
Research Advisor, Convatec Ltd
Jun 13 2022
They all delivered their subjects well; especially Janette Benaddi... 10/10
Anthonia Oluwatuyi
Quality Graduate, Bespak Europe Limited
Jun 13 2022
Overall, I loved all speakers. They all did an excellent job. I really liked the way Janette was structuring her talks with a lot of interactive questions and quizzes. That helped me in capturing the content better... Very good - would definitely recommend it.
Chloë Scheldeman 
R&D Manager Scientific Development, 2 Bridge
Jul 1 2019
A very well structured course with a logical progression through the regulations. The speakers aimed their knowledge at the right level.
Richard Oliver
Head of Technical and Clinical, STD Pharmaceutical Products Ltd
Jul 1 2019
The whole structure has been put together very well.
Dipti Patel
Cunsultant, SGR Consulting Services Ltd
Jul 2 2018
All speakers were really good, they captured my attention from the very first slide. Their presentations had a clear structure and easy to follow.
Cristina Stanca
Senior CMC specialist, Pharmedd Services Ltd
Jul 2 2018
Good clear presentations and great interactive sessions. Very informative and interesting. It was a fun learning experience.
Catherine Sutherland
Director, Drug Development Operations, Allergan Ltd
Jul 2 2018
Informative and interactive
Paridhi Dubey 
Regulatory Affairs Coordinator, Cochlear Ltd
Jul 3 2017
Greta, informative, well educated
Abdulrahman Al Saeed 
Saudi Food and Drug Authority
Jul 3 2017
The course helped to structuralize the knowledge on the regulatory requirements and helps to understand where each piece of the puzzle fits in. It was a very useful course to take.
Santa Popova 
Quality Control Manager , Light Guide Optics International
Jul 3 2017
The course helps to make sense of the requirements of MDD and MDR. I liked that both MDD and MDR were covered
Santa Popova
Quality Control Manager , Light Guide Optics International
Jul 3 2017
Overall it was an outstanding course - very specialist speakers but in some topics they should go deeper into details.
Abdulielah Al Mutairi
Senior Biomedical Engineer, Saudi Food and Drug Authority
Jul 4 2016
It was pretty good and helpful
Hadi Dhafer AlShehri
Registration and Licensing Specialist , Saudi Food and Drug Authority
Jul 4 2016
Excellent course for getting all the basic concepts
Anne Møller Nielsen 
IMM, Novo Nordisk
Jul 4 2016
Very professional but also personable
Susan Fotheringham
Principal Scientist, Oxford Cancer Biomarkers
Jul 4 2016
Great course and much information to digest now. Speakers were all very good and experienced within their subject.
Jes Schmidt-Petersen
Global Regulatory Affairs Manager, Ferring Pharmaceuticals A/S
United Kingdom
- Allergan Ltd
- Allergan UK Limited
- AstraZeneca
- Bayer Healthcare
- Bedfont Scientific Ltd
- Bespak Europe Limited
- Bray Group Ltd
- Britannia Pharmaceuticals Ltd
- Convatec
- ConvaTec LTD
- ConvaTec LTD (1006)
- Hospira UK Ltd
- Huntleigh Technology Ltd
- Johnson & Johnson Medical Ltd
- Kimal
- Lifescan Scotland Ltd
- Lombard Medical Ltd
- Marshall Products Ltd
- MSD Ltd
- Owen Mumford Ltd
- Oxford Cancer Biomarkers
- Pfizer
- Pharmedd Services Ltd
- Presspart
- Procter & Gamble
- Reckitt Benckiser Healthcare (UK) Ltd
- Sanofi-Aventis
- SGR Consulting Services Ltd
- Smith & Nephew Wound Management
- STD Pharmaceutical Products Ltd
- Thornton & Ross Ltd
- UCB Celltech Ltd
- University of Edinburgh
- University of Huddersfield
- Vectura
- Vision RT Ltd
- West Pharmaceutical Services Cornwall Ltd
Denmark
- Aarhus University
- Ferring Pharmaceuticals A/S
- Novo Nordisk
- Novo Nordisk A/S
- Novo Nordisk A/S Denmark
- Novo Nordisk AS
- NovoNordisk A/S
- Takeda Pharma A/S
Switzerland
- Acino Pharma AG
- Bioptron AG
- Cochlear Ltd
- Edwards Lifesciences SA
- F. Hoffmann-La Roche Ltd
- Novartis Consumer Health SA
- Rising Tide
- Thommen Medical AG
Italy
- Angelini Pharma
- Angelini Pharma S.p.A.
- CHIESI FARMACEUTICI S P A
- CID Spa
- Merc SRL/ISTUD
- Orthofix Srl
- Sigea Srl
Germany
- Dr Gerhard Mann chem pharm Fabrik Gmbh
- Eurocor GmbH
- Merz Pharmaceuticals GmbH
- Sanofi-Aventis Deutschland GmbH
- Vetter Pharma International GmbH
Netherlands
- Centocor BV
- Interdos Pharma BV
- Merck Sharp & Dohme
- University of Twente
Belgium
- 2 Bridge
- Ansell
- Modis
United States of America
- Acumed
- Coloplast
- Kimberly-Clark Corporation
Finland
- Oriola Oy
- Perkin Elmer
France
- Coloplast
- Guerbet
South Africa
- Medtronic
- Roche Products (PTY) Ltd
Spain
- Abbott Medical Optics
- Bayer Hispania SL
Sweden
- HemoCue
- Wellspect Healthcare
Austria
- Sandoz GmbH
Czech Republic
- Contipro Group s.r.o
Indonesia
- PT. Forsta Kalmedic Global
Japan
- Nihon Kohden Corp
Latvia
- Light Guide Optics International
Portugal
- Infarmed
Saudi Arabia
- Saudi Food and Drug Authority
Singapore
- Health Sciences Authority - Singapore
United Arab Emirates
- IPSEN
Run The Medical Device School - From Concept to CE Marking Live online/Classroom for your team
5 days
Typical duration
Pricing from:
- GBP 1,500
- 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:
