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.

1-5 Jul 2019

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

Book now

Course overview

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 appliatble to device development, marketing and eventually the post market procedures. There will be ample time for informal discussions alongide 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

Presenters

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.

Will Burton

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

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

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.

Book now

1-5 Jul 2019
1-5 Jul 2019 Rembrandt Hotel, London GBP 2,999.00
EUR 4,199.00
USD 4,678.00
+ VAT @ 20.00%
Enrol now

You may also be interested in

Previous customers include...

  • Abbott Medical Optics
  • Acino Pharma AG
  • Allergan Ltd
  • Allergan UK Limited
  • Bioptron AG
  • Centocor BV
  • Chiesi Farmaceutici S.p.a.
  • CID Spa
  • Cochlear Ltd
  • ConvaTec LTD
  • Dr Gerhard Mann chem pharm Fabrik Gmbh
  • F. Hoffmann-La Roche Ltd
  • Guerbet
  • Health Sciences Authority - Singapore
  • Hospira UK Ltd
  • Lifescan Scotland Ltd
  • Merc SRL/ISTUD
  • Merck Sharp & Dohme
  • Nihon Kohden Corp
  • Novartis Consumer Health SA
  • Owen Mumford Ltd
  • Roche Products (PTY) Ltd
  • Sanofi-Aventis
  • Sigea Srl
  • Smith & Nephew Wound Management
  • Takeda Pharma A/S
  • Thommen Medical AG
  • UCB Celltech Ltd
  • Vetter Pharma International GmbH
  • Wellspect Healthcare

Informative and interactive

Paridhi Dubey, Regulatory Affairs Coordinator, Cochlear 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

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

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

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

Excellent course for getting all the basic concepts

Anne Møller Nielsen, IMM, Novo Nordisk

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

It was pretty good and helpful

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

Very professional but also personable

Susan Fotheringham, Principal Scientist, Oxford Cancer Biomarkers