Medical Device Summer School: From Concept to CE Marking Including an Update on the New MDR (London, United Kingdom - July 1-5, 2019)
DUBLIN, May 23, 2019 /PRNewswire/ -- The "The Medical Device Summer School - From Concept to CE Marking" conference has been added to ResearchAndMarkets.com's offering
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.
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.
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 of bringing a device to market
- Network with participants from organisations similar to your own
Agenda:
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?
Discussion
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
Discussion
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
For more information about this conference visit https://www.researchandmarkets.com/r/8y88xx
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