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The Medical Device Summer School - From Concept to CE Marking Training Course

*A practical five-day course with interactive workshops - now in its 17th successful year!*

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.

5-9 Jul 2021

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Details

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

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.

Programme - Day one

What is a Medical Device?
  • Definitions and examples
Device design
  • 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
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

Discussion session

Classification of medical devices
  • How do you classify a medical device?

Classification workshop with case studies

Programme - 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?

Discussion session

Programme - 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

Discussion session

Clinical investigation/evaluation workshop

Approvals for conducting clinical studies
  • Documents required
  • Ethics committees
  • Competent authorities

Workshop session

Programme - Day four

Software and medical devices
  • Understanding the requirements for medical device software
  • Software qualification
  • Software classification
  • MDR and software considerations
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

Dicussion session

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

Dicussion session

Programme - 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

Discussion session

Workshop with case studies

Presenters

Janette Benaddi (More...)

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.

Will Burton (More...)

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, 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).

He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.

Mark Charny (More...)

Mark Charny has focused on evidence based medicine throughout his career. He qualified as a doctor and worked in general (family) practice before carrying out research into variations in clinical behaviour and their implications for guidelines and clinical audit. He obtained a PhD in identifying groups of patients in which health interventions are most cost-effective. He was a senior medical manager in the NHS for eight years, before spending two years at the UK Department of Health working on clinical effectiveness and clinical guidelines, including health needs assessment. He then became Director of the National Centre for Clinical Audit, which was funded by the UK government to promote clinical audit and quality improvement in the NHS.
In 1999, Mark founded Translucency. As Managing Director, he supports clients in the medical device, biotech, and pharmaceutical sectors in making the strongest possible business cases to payers in the UK and elsewhere in the EU. Translucency uses a blend of scientific, clinical, marketing and communications skills, market knowledge, and an extensive network of contacts in healthcare systems to advise and support clients who need to understand and manage the healthcare environment as it affects both new and existing products in a fast-moving environment.
He has published widely in the peer-reviewed medical literature and in other journals. He has spoken at many conferences to a wide variety of audiences, in the UK and abroad. He has refereed for peer-reviewed journals such as the British Medical Journal and Social Science in Medicine, as well as reviewing proposals for the NHS HTA programme.

Alison Wilson (More...)

Alison Wilson is an Independent Regulatory Affairs Consultant. Previously regulatory affairs manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in medicinal products, human tissue products and medical devices. She is a nominated UK expert for ISO (International Standards Organisation) TC150/WG 11 – Tissue Engineered Medical Products and a member of BSI Technical Panel RGM/1 – Regenerative Medicine.

Alison is a Module Advisor for the TOPRA* MSc in Regulatory Affairs (Pharma) (Module 9 – Biotechnology) and was Module Advisor for the MSc in Medical Technology Regulatory Affairs (Module 6 – Combination Products and Other Technologies) from 2006-2012. She is a member of the Topic Selection Panel for the MHRA Medical Device Technology Forum. She was a member of the MHRA (then MDA) working group responsible for production of the Code of Practice for Production of Human-Derived Therapeutic Products, 2002, and is the technical author for the BSI publication PAS 93: Characterisation of human cells for clinical application, published August 2011.

She is now Principal Consultant at CellData Service who provide strategic regulatory and development advice for a range of UK, EU and US clients seeking to develop and commercialise advanced therapy medicinal products (ATMPs), regenerative medicine therapies and drug-device combination products in the EU. She has extensive expertise in guiding smaller companies and academic groups through the regulatory complexities of development of novel regenerative medicine products, in particular scientific advice procedures and first-in-man clinical trials, and in recognition of this has received the first TOPRA Futures Award for contribution to regulatory science in new technology areas.

Greg Thay (More...)

Greg Thay is the founder and principle human factors consultant at THAY Medical, and has over twenty years’ experience in the medical and pharmaceutical industries. He has worked in many therapy areas (orthopaedics, infusion therapy, wound-care) before finding a vocation in human factors and usability engineering nearly a decade ago. He now leads the human factors engineering team at THAY Medical to assist large and small pharmaceutical and medical organisations to develop usable, safe and effective technologies. Recently, THAY Medical CE-Marked their first wearable drug delivery device, which Greg project managed and tested, to ensure its first-rate usability and timely completion. Greg also has been involved in the human factors and usability engineering of many drug delivery technologies, and loves nothing more than to present on this subject!

Koen Cobbaert (More...)

Koen Cobbaert is Quality and Regulatory Manager at Philips Healthcare. He represents COCIR in numerous work groups at European level. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries. In 2009 COCIR created its software task force, which Koen has been chairing ever since. He put on paper the first draft of the qualification decision tree, which was later successfully adopted by the Member States in “MEDDEV 2.1/6 on the qualification and classification of standalone software”. Under Koen’s leadership COCIR’s software task force has contributed to the 1st and 2nd edition of this MEDDEV and has proposed the IMDRF work item on software as a medical device, which ultimately lead to IMDRF guidance on the qualification, risk stratification and clinical evaluation of software as a medical device. Currently Koen’s work focuses on drafting the European guidance for classification of medical device software, which is expected to clarify among others the use of classification rule 10 and 11 under the Medical Device Regulation (MDR).
Koen wrote several COCIR papers on a variety of software-related topics under the MDR: qualification of and responsibilities for rules engines, programming and runtime environments and libraries for dataflow programming and machine learning, economic operator requirements for app stores and digital marketplaces, significant changes of software, UDI numbers, etc.Via COCIR’s standards focus group he contributed to the development of IEC 82304 on safety requirements for health software and IEC 62304 on software lifecycle processes. Koen co-authored the FAQ on IEC 62304, which has been translated in several languages. Via COCIR’s North American sister organisation MITA he also contributed to several FDA guidance papers, including the guidance papers on patient and clinical decision support systems and on computer-assisted detection devices applied to radiology images and radiology device data.
Koen has over 15 years of hands-on experience in establishing regulatory strategies, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software applications for general radiology, oncology, neurology, cardiology and orthopaedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps. He has a Master in Risk Management and Electrical Engineering.

Nick Baker (More...)

Nick Baker, is IVDR Certification Manager, with DNV GL Presafe AS. He was previously with Lloyds Register Quality Assurance Limited as IVD Technical Manager and was responsible for ensuring the technical integrity of the certification services provided by LRQA under the IVD and PPE directives. This involved ensuring that there were appropriate resources to meet client needs, assessing the impact of any regulatory changes and informing clients of the conformity assessment requirements to achieve CE certification for their products.
He started work in the pathology laboratories at the National Hospital for Nervous Diseases and then the Royal Free Hospital. He then moved into the diagnostics industry as a production scientist. During this time he undertook an MSc in Medical Biochemistry at Brunel University.

Book now

Book now

5-9 Jul 2021
Face-to-face, (venue not yet confirmed)
5-9 Jul 2021
Face-to-face
(venue not yet confirmed)
GBP 2,499.00
EUR 3,499.00
USD 3,898.00
Until 24 May 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 5 days of 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

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott Medical Optics
  • Acino Pharma AG
  • Allergan UK Limited
  • Bayer Healthcare
  • Bray Group Ltd
  • Britannia Pharmaceuticals Ltd
  • Centocor BV
  • Coloplast
  • ConvaTec LTD (1006)
  • Dr Gerhard Mann chem pharm Fabrik Gmbh
  • Edwards Lifesciences SA
  • Eurocor GmbH
  • F. Hoffmann-La Roche Ltd
  • Ferring Pharmaceuticals A/S
  • Hospira UK Ltd
  • Huntleigh Technology Ltd
  • Infarmed
  • IPSEN
  • Lombard Medical Ltd
  • Merc SRL/ISTUD
  • Merz Pharmaceuticals GmbH
  • MSD Ltd
  • Novartis Consumer Health SA
  • Owen Mumford Ltd
  • Procter & Gamble
  • Rising Tide
  • SGR Consulting Services Ltd
  • Thommen Medical AG
  • Thornton & Ross Ltd
  • Wellspect Healthcare

The whole structure has been put together very well.

Dipti Patel , Cunsultant, SGR Consulting Services Ltd, Jul 19

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 19

Informative and interactive

Paridhi Dubey, Regulatory Affairs Coordinator, Cochlear Ltd, Jul 18

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 18

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 18

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 17

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 17

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 17

Greta, informative, well educated

Abdulrahman Al Saeed, Saudi Food and Drug Authority, Jul 17

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, Jul 16

Very professional but also personable

Susan Fotheringham, Principal Scientist, Oxford Cancer Biomarkers, Jul 16

Excellent course for getting all the basic concepts

Anne Møller Nielsen, IMM, Novo Nordisk, Jul 16

It was pretty good and helpful

Hadi Dhafer AlShehri, Registration and Licensing Specialist , Saudi Food and Drug Authority, Jul 16