Sep 30 2009
Pilgrim Software, Inc., a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Nikki Willett, vice president of Marketing & Regulatory Affairs for Pilgrim, will address an audience of medical technology innovators at the ODT Conference & Exhibition 2009, October 7, in Fort Wayne, Indiana. Willett will be joined by medical device consultant Linda Lovett, president of Lovett Consulting, LLC, in a discussion of current and future international enforcement trends and issues related to supply chain compliance in the orthopedic industry.
“Quality in the Orthopedic Supply Chain – New Impacts to Think about” also will examine the impacts of GHTF Supplier Controls introduced in 2009 and the new MDD directive for 2010, and provide insight into effective ways to get to know suppliers and how to implement the right programs and controls for supply chain management.
“According to CDRH, device recalls were at an all-time high in 2008, and a lack of effective supplier management controls for device manufacturers is one of the major reasons for this growing problem,” Willett said. “With the new direction and enforcement trends from the FDA, more focus on sub-tier quality and control, and the impending impact from the EU's MDD, orthopedic manufacturers must take critical considerations related to effectively managing its company's supply chain compliance initiatives.”
The annual ODT conference features two days of supplier exhibits and targeted conference sessions where dual tracks - Engineering and Business Issues - put attendees in touch with industry thought leaders and critical information. The conference, October 6-8 at The Grand Wayne Convention Center in Fort Wayne, Indiana, features educational panels on a number of important topics highly pertinent to what is happening today in the MedTech industry. In attendance will be many of the world's leading Orthopedic minds, including manufacturers, designers and surgeons in the industry.