The Medical Device Summer 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.

6-10 Jul 2020

GBP 2,999
EUR 4,199
USD 4,678

Book now

Course overview

From concept to CE marking – including an update on the new Medical Device Regulation (MDR)

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. It will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, workshops and case studies covering each process applicable to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongside the presentations and workshops.

Bringing a Medical Device to the market place is a complex and lengthy procedure which requires experience, knowledge and specialist skills. The contribution to a successful market placement comes from many different skilled individuals and organisations. Those contributing towards the placing of devices on the market 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. It will commence with a general introduction as to what devices are and how they are developed, and continue with lectures, workshops and case studies covering each process applicable to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongside the presentations and workshops.

Benefits of attending this five day course

  • Understand the Procedures for Taking a Medical Device to the Market Place
  • Learn what Regulations Control the Manufacture and Marketing of Devices in the EU
  • Be Prepared for the Changes to the Requirements and the Impact of 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 course 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 throughout the course. It will be of particular interest to those seeking to introduce new Medical Devices to the market. Previous delegates who have benefited from this course include regulatory, quality, clinical and marketing managers.

Programme - Day one

  • Overview and objectives of the course
What is a Medical Device?
  • Definitions and examples
  • 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
Competent Authorities (CA)
  • What is a Competent Authority?
  • The role of a Competent Authority
  • The responsibilities of a Competent Authority
  • Relationships with manufacturers
Notified Bodies (NB)
  • What is a Notified Body?
  • The role of a Notified Body
  • The responsibilities of a Notified Body
  • Relationships with manufacturers

Workshop with Case Studies

Programme - Day two

Review of Day One

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?

Dicussion

Programme - Day three

Review of Day Two

Regulations and Guidelines Applicable to Medical Device Studies

  • Review of ISO 14155 and other available guidelines

Gathering Clinical Data for CE Marking

  • How to gather data, the Clinical Evaluation process

The Clinical Investigation Process

Clinical Evaluations

  • The practicalities associated with Clinical Investigations

Clinical Investigation / Evaluation Workshop

Documentation and Approvals for Conducting Clinical Studies

  • Documents Required
  • Ethics Committees
  • Competent Authorities

Workshop Session

Programme - Day four

Review of Day Three

In-Vitro Diagnostic Products
  • Exploration of the IVD Directive and its implementation
  • New regulations – the review of the IVD Directives
  • Impact of the user on compliance and Risk Analysis
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
Making sense of reimbursement, regulation and market access
  • Understanding different approaches adopted to the reimbursement of medical devices
  • Implications for manufacturers of medical devices
Working with Consultants, Contractors and Freelancers
  • Advantages and disadvantages of outsourcing
  • Ideal profile of an outsourcing partner
  • The key to a successful relationship

Dicussion

Programme - Day Five

Review of Day Four

Post Market Surveillance (PMS) What constitutes Post Market Surveillance – Basic principles of PMS
  • 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

Workshop with Case Studies

Presenter

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 now

6-10 Jul 2020
6-10 Jul 2020 Rembrandt Hotel, London GBP 2,999.00
EUR 4,199.00
USD 4,678.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

  • Aarhus University
  • Allergan UK Limited
  • Ansell
  • AstraZeneca
  • Bray Group Ltd
  • Chiesi Farmaceutici S.p.a.
  • CID Spa
  • ConvaTec LTD
  • ConvaTec LTD (1006)
  • Hospira UK Ltd
  • Kimberly-Clark Corporation
  • Light Guide Optics International
  • Lombard Medical Ltd
  • Merc SRL/ISTUD
  • Merck Sharp & Dohme
  • MSD Ltd
  • Nihon Kohden Corp
  • Novo Nordisk A/S
  • Oriola Oy
  • Oxford Cancer Biomarkers
  • Perkin Elmer
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Roche Products (PTY) Ltd
  • Sandoz GmbH
  • SGR Consulting Services Ltd
  • Sigea Srl
  • STD Pharmaceutical Products Ltd
  • Thornton & Ross Ltd
  • UCB Celltech Ltd
  • Wellspect Healthcare

The whole structure has been put together very well.

Dipti Patel , Cunsultant, SGR Consulting Services Ltd

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

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

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, CMC specialist, MSD

Informative and interactive

Paridhi Dubey, Regulatory Affairs Coordinator, Cochlear Ltd

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

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

Greta, informative, well educated

Abdulrahman Al Saeed, , Saudi Food and Drug Authority

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

Excellent course for getting all the basic concepts

Anne Møller Nielsen, IMM, Novo Nordisk

It was pretty good and helpful

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

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

Very professional but also personable

Susan Fotheringham, Principal Scientist, Oxford Cancer Biomarkers