Regulatory Approvals in China, 510(k) Guidance Among This Years’ Discussion Topics


(Chicago, IL) – For the fourth straight year, Q1 Productions will host the annual Medical Device Regulatory Clearance and Approval Conference, offering regulatory affairs professionals exclusive insight to the latest trends and newest happenings within the industry.  The conference will take place November 3-4, 2014 in Arlington, Virginia.


This year, a variety of new session topics will be on the agenda addressing several hot topics, including 510(k) guidances, regulations for product approval in China, updates on the European directives, and gaining approval of mobile medical applications.  Among the nearly two dozen legal and industry speakers set to present are Mark Duval of Duval & Associates, Herbert Lerner of the FDA, Gemma Moore of Edwards Lifesciences, and Robert Steele of Stryker.


As medical device manufacturers seek to gain clearance and approval for products in other countries, sessions at this conference will focus on culture communication with distributors and foreign agencies.  Attendees will have the opportunity to network and discuss the 2014 revision of the Chinese medical device regulations and gain exclusive insight to the challenges of navigating new Chinese clearance and approval processes including clinical trials, labeling requirements and CFDA communication and processing timelines.


For more information or to register for the 4th Annual Medical Device Regulatory Clearance and Approval Conference, please visit  You can also follow Q1 Productions on Twitter @Q1productions, #q1MDRC.