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FDA and Industry Experts Meet to Discuss Postmarket Surveillance

12-09-2016 09:19 AM CET | Health & Medicine

Press release from: Q1 Productions

Implementing an Effective & Agile Postmarket Surveillance System, Transitioning to the New EU MDR and Adhering to the new ISO 13485:2016

(Alexandria, VA) On February 23-24, 2017 Q1 Productions will host their 3rd Annual Global Postmarket Surveillance Of Medical Devices Conference in Alexandria, VA. Over 14 distinguished presenters are to attend, including four representatives from the FDA. This conference is one of a kind in networking, workshops and presentations.

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.

About Q1 Productions:
Q1 Productions designs and develops webinars, training courses, conference programs and forums aimed at specifically targeted audiences in order to provide strategic and timely information. Through a rigid production process focused on end-user research and design, our team is able to understand the immediate business concerns of today’s leading executives. Whether focusing on new or pending legislative issues, enhanced business processes or technologies that will drive efficiency and customer service, our programs provide solutions to the urgent needs of our attendees.

For more information on the Medical Device Corporate Strategy and Business Development Conference, or any of Q1 Productions’ upcoming conferences, please visit You can also follow Q1 Productions on Twitter,@Q1Productions, #BizDev16.

Lydia Welmer
Q1 Productions
500 N. Dearborn Suite 500
Chicago, IL 60654

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