“Complaints, MDRs, Reports of Removals & Corrections, and Recalls, presented by the Medical Technology Learning Institute (MTLI), was held January 20-21 in Orlando, FL, Kacera delivered 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.
“While the FDA has not yet passed a formal date for when the eMDR process will be mandatory, it has reiterated numerous times that it will be mandatory, so it’s good to see that more companies now are moving toward eMDR” Kacera said. “It’s a long process and there are companies that are just now starting to get educated on what eMDR is and what their options are for being able to meet this requirement. But they’re moving ahead because they are aware there will be cost savings, timeliness of data sharing and increased accuracy of information that both medical device companies and the FDA will be able to leverage.
“When I started speaking on the topic of eMDR almost two years ago, there were only a couple of companies that even knew what it was,” she added. “Now when I ask the question, Who knows?, I find almost the entire audience at the appropriate awareness level. During the complaints conference it was evident based on audience questions, that many companies are in the process of going live or in the initial implementation phase of their own eMDR programs.”
In the past two 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.
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.
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.