"Quality in the Orthopedic Supply Chain".

Pilgrim Software's Regulatory Expert to Address Industry at 2009 ODT Conference

TAMPA, Fla. -- 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.

Nikki Willett is vice president of Marketing & Regulatory Affairs for Tampa, FL-based Pilgrim Software. She is responsible for managing all aspects of Pilgrim's worldwide product, industry and corporate marketing initiatives. She is a seasoned professional with an extensive background in high tech marketing, technology and regulatory industries. With over 25 years in software, Nikki has focused on advancing technology through the constant evaluation of business trends to help organizations progress and succeed through the use of automation. She has participated in standard committees for the creation of digital standards with the FDA for new drug application (NDA) submissions and for the Air Transport Association (ATA). She is an active member of leading trade and industry associations such as AdvaMed, as well as RAPS, PDA, ISBT, ASQ and AABB representing the industries Pilgrim services. She currently acts as Pilgrim's spokesperson and educator concerning quality, safety, risk and compliance at leading trade conferences, seminars, and universities, and has published many industry articles. She founded and is the Group Owner of LinkedIn's QA & RA Network Group, having more than 8,000 members, to help professionals in sharing ideas and best practices in quality, regulatory, safety, health, sustainability, lean, security, risk and compliance.

Linda Lovett has 17 years experience providing strategic and tactical quality assurance leadership in the medical device industry, focusing on rapid growth and regulatory compliance environments. She has embraced multiple quality assurance positions with increasing responsibility throughout her career. She held the quality systems director and management representative position for Kyphon, Inc., now a Medtronic company. She led Kyphon, Inc. to successfully achieve and maintain certification to ISO 13485:2003 and in successful outcomes during FDA and other agency inspections during aggressive company growth. Prior to joining Kyphon, Inc., Ms. Lovett held many advancing quality assurance positions with Abbott Laboratories in their hospital products and diagnostics divisions. Prior to working in the medical device industry, she held various sales management positions over 10 years. She received her bachelor of science degree from Michigan State University in zoology, with additional emphasis in chemistry and mathematics.

About Pilgrim Software, Inc.

Pilgrim Software, Inc. is a world-leading provider of Enterprise Compliance and Quality Management solutions for global organizations. Named 2007 & 2008 North American Enterprise Compliance & Quality Management Company of the Year by Frost & Sullivan, Pilgrim helps organizations manage industry and regulatory compliance, reduce manufacturing costs and improve customer satisfaction. For more information, visit Pilgrim Software's website at www.pilgrimsoftware.com.