Gathering as an Industry to Exchange Best Practices for Implementing an Effective & Agile Postmarket Surveillance System, Transitioning to the New EU MDR, Adhering to the new ISO 13485:2016, and Remaining at the Forefront of Evolving Markets across the Globe.
ABOUT THE CONFERENCE
Regulatory bodies across the world are placing increased importance on monitoring the safety and efficacy of medical devices in the global marketplace and as such, the role of post market surveillance within medical device organizations has expanded far beyond complaint handling. Device manufacturers must transform the surveillance of their products from reactive to proactive, which requires the development and implementation of robust and agile systems to manage the surge of post approval data. As more manufacturers enter the global marketplace, ensuring quality systems are able to withstand the reporting requirements for multiple, and often conflicting countries and regions is of utmost importance.
The Global Post Market Surveillance of Medical Devices conference brings an unprecedented level of knowledge share to post market surveillance challenges, highlighting ISO 13485:2016, the latest FDA Post Market Surveillance Guidance, and implications of the new EU MDR. Other key areas of discussion include transitioning from premarket trials to post approval studies, optimizing eMDR for more effective oversight, and the latest regulatory updates from China and Brazil. Through case-study driven presentations, interactive workshops, high-level keynote sessions, as well as provocative roundtable panel discussions complemented by multiple networking opportunities, the program will foster a sense of industry-wide collaboration.
“I really appreciated the meeting. In my opinion it was even better than last year. Very high quality and good discussions.”
– Manager Post-Market Studies EMEA, Abbott Medical Optics
“Thank you very much for your feedback and for the great organization of the event! I really enjoyed the conference, it was very interesting and stimulating.”
– Investigator Initiated Studies Manager (CIRAC Project Manager), Global Post-Approval Operations & Medical Affairs, Actelion Pharmaceuticals
500 N. Dearborn Suite 500 | Chicago, IL 60654
Chicago, IL 60654