RAPS Texas Chapter

Recent Developments in Medical Device Regulation

14 June 2012
United Way of Greater Houston
Houston, TX

Join your regulatory colleagues from across the Houston area for an evening of networking and an expert presentation entitled, “Recent Developments in Medical Device Regulations.” This meeting is sponsored by the RAPS Texas Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.

This presentation will update participants on the latest developments in medical device regulation around the globe and will discuss the change from the Global Harmonization Task Force to the International Medical Device Regulators Forum.

Topics to be covered will include:

• The PIP scandal and its impact on the European Medical Device Regulatory System
• The recast of the EU Medical Devices Directive
• The revamp of key EU Harmonised Standards, starting with ISO13485:2012
• Recent MEDDEVs
• Recent (and last!) documents from GHTF
• The end of GHTF and the creation of the International Medical Device Regulators Forum
• Health Canada’s new GD211
• FDA’s new pilot program for ISO13485 audits

A light meal will be provided for all attendees and participants are eligible to claim two (2) continuing education and/or RAC recertification points.