Dublin, June 29, 2021 (GLOBE NEWSWIRE) -- The "The Medical Device Summer School - From Concept to CE Marking Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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.
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.
Key Topics Covered:
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
For more information about this conference visit https://www.researchandmarkets.com/r/rpmta