Medical Device Congress can help QSR professionals improve quality systems

Medical Product Outsourcing, June, 2008

Quality Systems Regulation (QSR) professionals will play a central role in this year's Medical Device Quality Congress.

The fifth annual event will feature workshops designed to help QSR professionals better understand federal regulations governing the manufacture and marketing of medical devices. It also will outline ways companies can improve their quality systems, reduce risk and constructively solicit customer feedback.

The event, to be held June 25-27 at the Royal Sonesta Hotel Boston in Cambridge, MA, will include two pre-conference workshops and a panel discussion on risk management. One workshop will provide an overview of the FDA process, while the other one will explain ways companies can develop standard operating procedures using a quality systems approach. Most workshops at the main event were designed to help QSR professionals improve quality systems at their companies. Furthermore, areas such as product recalls will be discussed.

In addition, FDANews and Industry Directions Inc. will release the results of a survey on current industry challenges and practices. Survey findings will be shared during a special session on risk management and best practices for medical device profitability.

Featured speakers at the Congress include Tim Ulatowski, director of the FDA's Office of Compliance; Thomas Sommer, president of the Massachusetts Medical Device Industry Council, and Denise Dion, a senior regulatory consultant at EduQuest Inc. and former FDA medical device investigator liaison between the Office of Regulatory Affairs and the Center for Devices and Radiological Health.

For more information about the meeting, dubbed "Leading the Way to Better Performance with Quality Systems Compliance," sit www.fdanews.com/medicaldevice or contact FDANews at (888) 838-5578.