TAMPA, Fla.--(BUSINESS WIRE)--Pilgrim Quality Solutions, a leading global provider of enterprise quality management software and services for the Life Sciences, today announced that Deborah Kacera, Regulatory & Industry Strategist for Pilgrim, will join an exclusive panel discussion on electronic medical device reporting (eMDR) at FDAnews’ 12th Annual Medical Device Quality Congress, March 17-19, in Bethesda, Maryland.
During the session, The eMDR Challenge — Test Your Adverse Event Reporting and Implementation Expertise, Kacera will join panel moderator Steve Niedelman, former FDA Deputy Associate Commissioner for Regulatory Operations, and Patrick Caines, Director of Product Surveillance for GE Healthcare, to explain options for implementing an eMDR system, and what the FDA is looking for in MDR reporting
“Time is ticking in the medical device community, with the FDA’s August 14, 2015 deadline for mandatory electronic reporting looming,” Kacera said. “I’m looking forward to sharing the lessons learned from experiences that early-adopters have already encountered in recent years. I’ll be taking the audience through case studies and real-world examples of eMDR implementations at small, medium and large companies, and I’ll highlight the best practices that helped them succeed along the way.”
Additional discussion from the panel will address the current requirements for MDRs on events occurring outside the US; reporting requirements when no injury has occurred; number of reports to file when there are multiple occurrences; and, what to do in “User Error” situations.
About Pilgrim Quality Solutions
Pilgrim Quality Solutions is a leading global provider of enterprise quality management software and services for the Life Sciences and other highly regulated industries. For more than 20 years, our solutions have automated thousands of processes that ensure the quality of life’s most important products. Product quality and patient safety increase while risks decline. Our on-premise and cloud technologies reflect quality industry standards and include electronic signatures, audit trails and validation packs - helping customers more easily achieve compliance and pass regulatory audits. With Pilgrim Quality Solutions as your partner, you are prepared to succeed. For more information, visit www.pilgrimquality.com.