Practical Approaches to the Timely Implementation of MDR-IVDR Regulatory Requirements through the Development & Initiation of a Coherent Transition Framework, Meeting Enhanced Notified Body & Competent Authority Expectations while Eliminating the Risk of Supply Chain Disruption
For the past 5 years, regulatory affairs executives have been closely monitoring advancements in the development of new regulatory frameworks for the medical device and diagnostic industries, to ensure a proactive approach to new provisions. The MDR and IVDR have been designed to guarantee a higher level of safety, scrutiny and transparency in the European healthcare market and, as such, disrupt current regulatory strategies responding to the soon outdated directives. While regulatory affairs executives now have a commonly good perception of upcoming requirements, grey areas and misconceptions remain to be clarified particularly for legacy product management, clinical operations, supply chain and post-market control. Further, it is the practical application of company-wide regulatory strategy revision and implementation that raises most concern, as transition timelines are considered to be limited.
The conference’s in-depth focus on the MDR & IVDR 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 and tracked interactive session formats will allow delegates from each industry to engage in hands-on activities with peers and thought industry leaders, 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 making this event the must-attend program for forward-thinking regulatory affairs 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.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
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