Clarifying Critical Provisions from the EU MDR & Addressing Evolving Collaborations with Notified Bodies, all while Conducting Regulatory Gap Assessments & Initiating In-House Strategy Revisions
ABOUT THE CONFERENCE
With the EU Medical Device Regulation’s recent publication, the device industry is currently analyzing gap assessment strategies to have a clear perspective of areas impacting corporations. With provisions spanning all levels of device companies, the new regulation must be carefully interpreted and understood, in order to ensure a smooth transition in time and on budget. One of the most prominent changes affect the role and responsibilities of notified bodies, which are now required to collaborate more closely and transparently with competent authorities. This new role generates much concern from the industry, eager to learn more about challenges in new collaborations terms as well as notified body accreditation, and the necessity to change notified bodies in the case of accreditation disapproval. Among other areas of challenge are the enhanced requirements for data pertinent to clinical research and quality management systems, along with new formats for technical files.
The conference’s in-depth focus on the EU Medical Device Regulation will ensure a holistic approach to current changes in the European Union, providing participants with a plethora of enlightening solutions to complex regulatory transitions. High-level presentations will be delivered by European and US-based speakers to ensure the highest level of education, and interactive formats will also allow delegates to engage in hands-on activities aiming to build experience in conducting thorough regulatory gap assessments and developing a specific regulatory strategy updating plan. With so many regulatory changes to interpret and implement, manufacturers are looking for expert insights, which will be delivered by a host of presenters including Notified Bodies, Competent Authorities and renowned industry executives.
This conference has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.