Presented by
Management Forum

The Medical Device School - From Concept to CE Marking

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.

13-17 Dec 2021 + 2 more dates

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  • Format: Live online
  • 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

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.

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The The Medical Device School - From Concept to CE Marking 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

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

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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.

More details

Book The Medical Device School - From Concept to CE Marking Live online training

13-17 Dec 2021

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11959

  • GBP 1,999 2,499
  • EUR 2,549 3,249
  • USD 2,969 3,749

Until 08 Nov

In your basket 

13-17 Jun 2022

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 11831

  • GBP 1,999 2,499
  • EUR 2,549 3,249
  • USD 2,969 3,749

Until 09 May

In your basket 

5-9 Dec 2022

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 11832

  • GBP 1,999 2,499
  • EUR 2,549 3,249
  • USD 2,969 3,749

Until 31 Oct

In your basket 

Reviews of IPI's The Medical Device School - From Concept to CE Marking training course


A very well structured course with a logical progression through the regulations. The speakers aimed their knowledge at the right level.

Jul 1 2019

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

UK

  • Allergan Ltd
  • Allergan UK Limited
  • AstraZeneca
  • Bayer Healthcare
  • Bray Group Ltd
  • Britannia Pharmaceuticals Ltd
  • ConvaTec LTD
  • ConvaTec LTD (1006)
  • Hospira UK Ltd
  • Huntleigh Technology Ltd
  • Kimal
  • Lifescan Scotland Ltd
  • Lombard Medical Ltd
  • Marshall Products Ltd
  • MSD Ltd
  • Owen Mumford Ltd
  • Oxford Cancer Biomarkers
  • 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
  • Vectura
  • 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

Germany

  • Dr Gerhard Mann chem pharm Fabrik Gmbh
  • Eurocor GmbH
  • Merz Pharmaceuticals GmbH
  • Sanofi-Aventis Deutschland GmbH
  • Vetter Pharma International GmbH

Italy

  • CHIESI FARMACEUTICI S P A
  • CID Spa
  • Merc SRL/ISTUD
  • Orthofix Srl
  • Sigea Srl

Netherlands

  • Centocor BV
  • Merck Sharp & Dohme
  • University of Twente

United States of America

  • Acumed
  • Coloplast
  • Kimberly-Clark Corporation

Belgium

  • Ansell
  • Modis

Finland

  • Oriola Oy
  • Perkin Elmer

France

  • Coloplast
  • Guerbet

South Africa

  • Medtronic
  • Roche Products (PTY) Ltd

Spain

  • Abbott Medical Optics
  • Bayer Hispania SL

Austria

  • Sandoz GmbH

Czech Republic

  • Contipro Group s.r.o

Japan

  • Nihon Kohden Corp

Latvia

  • Light Guide Optics International

Portugal

  • Infarmed

Saudi Arabia

  • Saudi Food and Drug Authority

Singapore

  • Health Sciences Authority - Singapore

Sweden

  • Wellspect Healthcare

United Arab Emirates

  • IPSEN

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy