Developing & Implementing Robust Plans to Gather Compliant Post-Market Clinical Follow-Up Data, Practically Defining Clinical Evidence Based on Device Class & Acceptable Information, all while Sharing Solutions to Operational Challenges in Cost-Effective Data Collection
As medical device manufacturers navigate the changing industry landscape in preparation for the European Medical Device Regulation, one of the most pressing requirements facing clinical research executives is the enhancement of post-market clinical follow-up, surveillance, and reporting strategies. Placing a major focus on real-world evidence, the MDR presents professionals in clinical research with numerous challenges as they seek to provide an accurate representation of each device’s performance and safety once on the market. While the volume and sources of data that will be required by competent authorities and notified bodies to support each device’s continued market presence remains uncertain, leaders in the field recognize the urgency of developing and implementing compliant plans for the collection of relevant and sufficient data while working to contain costs.
The Q1 Productions EU Medical Device Post-Market Clinical Evaluation Planning Conference will provide insight into practical solutions implemented by medical device firms to determine the appropriate level of evidence needed, and to develop plans to meet enhanced post-market clinical follow-up requirements. Focused working groups and peer-to-peer discussion will allow for the sharing of strategies to optimize cost-effective data collection while addressing challenges relating to registry data ownership, privacy concerns, physician motivation, and much more. Industry leaders seeking proactive methods by which to demonstrate device safety under the new requirements of EU MDR will find this conference a must-attend educational event.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | firstname.lastname@example.org