Medical Device Conformity Assessment Under the European Medical Devices Regulation (EU) 2017/745
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.
This course 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.
Who should attend?
- Medical device regulatory affairs professionals
- New personnel to the medical device industry
- Those transferring from the pharmaceutical industry to medical devices
- Quality managers and quality assurance personnel
- Business development professionals