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
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?
What Regulations Control the Manufacture and Marketing of Devices in the EU?
How Does a Device obtain a CE Mark?
Economic operators, competent authorities and Notified Bodies
Classification of medical devices
Classification workshop with case studies
Programme - Day two
Risk analysis and risk management
How Should a Risk Analysis be Conducted? - Risk Analysis Workshop
Biological Evaluation of Medical Devices
Technical Files and Design Dossiers
Quality Systems for Medical Devices
Labelling and Packaging of Devices
Programme - Day three
Regulations and guidelines applicable to medical device studies
Conducting medical device clinical investigations
Documents necessary for medical device clinical investigations
Clinical investigation/evaluation workshop
Approvals for conducting clinical studies
Programme - Day four
Software AG and medical devices
In-vitro diagnostic products
Making sense of the European reimbursement environment
Devices incorporating materials of animal origin
Programme - Day Five
Post-market surveillance (PMS)
EC medical device vigilance
Workshop with case studies
For more information about this conference visit https://www.researchandmarkets.com/r/rpmta
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