The first Enterprise Quality Management Solution in the industry with expanded capabilities for European Union Medical Device Regulation regulations and compliance
DANBURY, Conn. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–IQVIA™ (NYSE:IQV) today announced the launch of its latest release of the IQVIA SmartSolve® Enterprise Quality Management Solution (EQMS). This marks the world’s first EQMS to provide expanded quality, regulatory, and safety compliance support for the new European Union Medical Device Regulation 2017/745/EU (EU MDR). This includes support for the new Manufacturer Incident Report (MIR) requirements and timelines, enhanced design control functionality, and expanded risk management capabilities.
“The European Union Medical Device Regulation and the comparable regulatory changes for in vitro diagnostics present the largest impact on the industry in its history, and this impact is not limited to companies operating within the EU,” said Bhavik Patel, senior vice president, IQVIA MedTech. “IQVIA SmartSolve EQMS is the first solution in the market to be expanded to include support for EU MDR.”
EU MDR are medical device regulations that take full effect on May 26, 2020, replacing existing standards. The new requirements mandate that devices be more traceable throughout the supply chain and product lifecycle, spanning clinical development to commercial distribution. A key objective of the MDR is to increase use and speed of clinical evaluations, data evidence, and detailed reporting to improve patient safety, outcomes, and overall experience.
“IQVIA Quality Compliance and our Vigilance and Safety teams have extensive experience to support customers as they work to become MDR compliant,” said Tal Rosenberg, senior vice president, Technology Solutions at IQVIA. “We can help MedTech companies navigate the new regulatory landscape of the EU MDR and provide orchestrated solutions that will support customer efforts to drive regulatory adherence and operational excellence.”
IQVIA MedTech is dedicated to serving the medical device and in vitro diagnostics market with innovative solutions and services, enabling companies to improve their business operations across their entire product lifecycle, from concept to market, including providing orchestrated quality control, regulatory, safety and compliance solutions. With access to cutting-edge technology and deep domain expertise, IQVIA MedTech breaks down silos across the product lifecycle, from clinical to commercial, and provides information at a geographic scale to drive growth and expansion globally.
For more information about the IQVIA SmartSolve EQMS, visit https://www.iqvia.com/our-customers/medical-technology/quality-regulatory-safety-and-compliance.
IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry. Formed through the merger of IMS Health and Quintiles, IQVIA applies human data science — leveraging the analytic rigor and clarity of data science to the ever-expanding scope of human science — to enable companies to reimagine and develop new approaches to clinical development and commercialization, speed innovation and accelerate improvements in healthcare outcomes. Powered by the IQVIA CORE™, IQVIA delivers unique and actionable insights at the intersection of large-scale analytics, transformative technology and extensive domain expertise, as well as execution capabilities. With approximately 61,000 employees, IQVIA conducts operations in more than 100 countries.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing information on a scale that helps healthcare stakeholders identify disease patterns and correlate with the precise treatment path and therapy needed for better outcomes. IQVIA’s insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.iqvia.com.
Tor Constantino, IQVIA Media Relations ([email protected])
Andrew Markwick, IQVIA Investor Relations ([email protected])