DUBLIN--(BUSINESS WIRE)--The "Medical Device Conformity Assessment Under the European Medical Devices Regulation (EU) 2017/745: Obtaining the CE Mark" conference has been added to ResearchAndMarkets.com's offering.
This seminar will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark
This course will show you how to plan for and undertake the conformity assessment process for your medical device to demonstrate that your product meets the enhanced requirements of the new Medical Devices Regulation (MDR).
As with the current Directive, the choice of conformity assessment route depends on the classification of the device. Once you have undergone a valid conformity assessment process and shown that your device has met the new requirements, you will be in a position to place a CE mark on your product which is your access to the European market.
The programme will provide essential guidance on how to undertake a successful conformity assessment process and subsequently apply (or continue to apply) the CE mark. The importance of quality management systems, risk management, the use of standards and the current status of implementing acts, common specifications and published guidance will be a particular focus. This is an excellent opportunity to understand the requirements and regulations and to discuss the complexities with two experts in this field.
Programme day one
Overview of the new MDR requirements
- The General Safety and Performance Requirements (SPRs)
- UDI and Eudamed
- The post-market phase
- Future developments
- Implications of Brexit
The CE marking process under the MDR
- What is the CE mark and what does it mean?
- When do you need one?
- When don't you need one?
Deciding on the most appropriate assessment route for your product
- Class I devices
- Class IIa devices
- Class IIb devices
- Class III devices
Conformity assessment route workshop
Programme day two
Notified Bodies under the MDR and the role of Competent Authorities
- Choosing your Notified Body (NB)
- The role of Competent Authorities and other interested parties
- What you need to do to prepare
Demonstrating compliance with harmonised standards
- Current status of harmonised standards under the MDR
- ISO 13485 covering quality management systems for medical device manufacturers
- ISO 14971 covering risk management for medical devices
- Other process-specific standards, such as those covering sterilisation
- Standards for medical devices, active implantable medical devices
Quality management systems (QMS) and risk management workshop
Feedback and discussion
- What is a clinical investigation?
- When do you need to do one?
Feedback and discussion
Russell Square Quality Representatives (RSQR) Ltd
Regulatory Affairs Manager
For more information about this conference visit https://www.researchandmarkets.com/r/l6m6o2