Elsevier Supports Improved Post-Market Surveillance for Medical Devices through Seamless Access to Biomedical Data Available from Embase

Embase facilitates compliance with regulatory guidelines and competitive analysis for product development

New York, October 28, 2014

Elsevier, a world-leading provider of scientific, technical and medical information products and services, today announced Embase, the world's most comprehensive biomedical database that enables tracking and retrieval of drug-specific data, has been enhanced to support the retrieval of medical device information. The improvements support comprehensive post-market surveillance and device safety as well as the development of novel devices.

Embase, which is part of the Elsevier Life Science Solutions portfolio, will help users prepare for clinical evaluations and perform post-market surveillance for medical devices more effectively through newly added functionality.

Medical device manufacturers using Embase will be able to carry out systematic reviews and compile a range of technological reviews including health technology assessments, rapid advisories, comparative effectiveness reviews and clinical evaluations for a medical device. Users will be able to monitor the literature for adverse device effects, emerging public health threats, quality complaints and inaccurate or inappropriate statements on devices.

"Whether monitoring adverse device effects to comply with post-market surveillance or developing a novel device, searching and identifying medical device-specific information in the literature is critical for manufacturers," said Daan de Jong, Director of Product Development, Elsevier. "As the body of scientific literature continues to expand, carrying out this comprehensive monitoring is becoming a significant challenge. Embase boasts wide literature coverage and now has dedicated functionality for medical devices, so manufacturers can feel confident they have tools to be fully compliant."

Data from Embase can be delivered in a flexible manner, allowing for better integration with customers' existing workflows and tools for post market surveillance. Customers can also incorporate data into their alerting systems to drive a more effective monitoring process with comprehensive information on regulatory changes and adverse events. Additionally, Embase works together with QUOSA, Elsevier's scientific literature management solution supporting retrieval, storage, tagging and annotation of scientific literature to deliver an end-to-end workflow for the screening, organizing, archiving and sharing of medical device literature.

Embase customers were automatically upgraded to a new version on July 31, 2014. Others interested in learning more about Embase and Elsevier's pharmacovigilance solutions can request additional information at: http://www.elsevier.com/online-tools/embase/contact-sales.

---

About Elsevier Life Science Solutions
Elsevier Life Science Solutions is a portfolio of domain-specific decision support tools, including ScienceDirect, Pathway Studio®, Reaxys®, Reaxys® Medicinal Chemistry, Embase™ and PharmaPendium®. Designed by scientists for scientists, the tools work together to help you create innovative drug therapies and reduce the time and cost of bringing them to market.

About Elsevier
Elsevier is a global information analytics company that helps institutions and professionals progress science, advance healthcare and improve performance for the benefit of humanity. Elsevier provides digital solutions and tools in the areas of strategic research management, R&D performance, clinical decision support, and professional education; including ScienceDirect, Scopus, ClinicalKey and Sherpath. Elsevier publishes over 2,500 digitized journals, including The Lancet and Cell, more than 35,000 e-book titles and many iconic reference works, including Gray's Anatomy. Elsevier is part of RELX Group, a global provider of information and analytics for professionals and business customers across industries. www.elsevier.com

Media contact
Amy Burnis
Director, Strategic Communications
Elsevier
+1 617 803 8344
a.burnis@elsevier.com