Tampa, FL – October 5, 2009 -- Pilgrim Software, Inc. , a world-leading provider of Enterprise Compliance and Quality Management (ECQM) software solutions, today announced that Deb Kacera, Senior Product Manager, Regulatory Products, for Pilgrim, will address an audience of prominent medical device industry experts at MTLI’s 2009 regulatory workshop on Complaints, MDRs, Reports of Removals & Corrections, and Recalls. Kacera will present a comprehensive look at the basis for and the benefits of electronic medical device reporting (eMDR) using today’s available solutions.

The workshop will be presented by the Medical Technology Learning Institute (MTLI), October 22-23 in Chicago. This two-day program, for the first time in the Chicago area, covers current practical and policy issues in US and international adverse event reporting. Kacera will deliver a compelling presentation on the FDA’s electronic MDR program, the process of implementing an eMDR program, the practical challenges of eMDRs, and lessons learned from early adopters.

“Since the Proposed Rule to make eMDRs mandatory was released on August 21, 2009, companies are starting to get educated on what eMDR is and what their options are for being able to meet this requirement,” Kacera said.  “Compliance will generate cost savings, timeliness of data sharing and increased accuracy of information for both device manufacturers and the FDA.”

Over the past two and a half years, Kacera has worked closely with the FDA to contribute her expertise and insights to planning and development of the new CDRH eMDR program and Pilgrim’s new eMDR functionality.  Specifically, she has provided recommendations to the FDA regarding additional and adjusted content for eMDR document requirements and input into coding changes to improve the efficiency of the eMDR submission process. Kacera has been invited to participate in the FDA’s Problem/Adverse Event Codes Working Group. As a leading subject matter expert in eMDR technology, she has been invited to speak on eMDR at numerous prestigious conferences and seminars in both the U.S. and Europe. She is working with BfArM on the latest eMEDDEV requirements emerging in the EU.

Kacera was named one of the “100 Notable People” in the medical device industry in 2008 by MD&DI magazine.  As Senior Product Manager at Pilgrim Software, she is responsible for the company’s CAPA and Complaints management software products.  She determines specifications for product enhancements, new products and third-party product integration.  She supports Pilgrim’s products through all stages of their lifecycles, including conception, definition, development, release and post-release activities.  She works closely with customers, associations and regulatory bodies, including the FDA and European Notified Bodies, to generate requirements for future products and enhancements.


About MTLI
MTLI offers a variety of educational programs including regulatory, technical, and professional training courses covering all facets of the medical technology business lifecycle. Faculty are drawn predominantly from AdvaMed member companies and government, complemented by a cadre of industry thought leaders.  www.advamedmtli.org

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’s website at www.pilgrimsoftware.com.