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The Medical Device School - From Concept to CE Marking Training Course
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.
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 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
Presenter
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.
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13-17 Dec 2021 Live webinar |
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13-17 Dec 2021 Live webinar |
GBP 2,499 1,999 EUR 3,249 2,549 USD 3,749 2,969 Until 8 Nov* |
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to attend Live webinar |
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13-17 Jun 2022 Live webinar |
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13-17 Jun 2022 Live webinar |
GBP 2,499 1,999 EUR 3,249 2,549 USD 3,749 2,969 Until 9 May 22* |
Enrol now
to attend Live webinar |
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5-9 Dec 2022 Live webinar |
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5-9 Dec 2022 Live webinar |
GBP 2,499 1,999 EUR 3,249 2,549 USD 3,749 2,969 Until 31 Oct 22* |
Enrol now
to attend Live webinar |
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