HORSHAM, Pa., Feb. 24, 2022 /PRNewswire/ -- In response to the needs expressed by medical device manufacturers for ways to effectively manage the product lifecycle from conception through regulatory clearance and post-market activities, Reed Tech, a leading provider of data management and analytics solutions for the life sciences industry, is building an alliance of world-class solution providers, a collective of regulatory experts delivering solutions and services who support manufacturers, distributors and related operations. Answering the call for innovation in quality management systems, Reed Tech has expanded its collaboration with Greenlight Guru, the pioneer of the only dedicated Medical Device Success Platform (MDSP), serving the specialized workflows of manufacturers. Current and prospective customers of both companies can leverage exclusive benefits as part of this new strategic alliance.
"Implementation of Unique Device Identification (UDI) product data within US FDA, EU EUDAMED, China NMPA, South Korea MFDS, and other health authority databases creates complexity for medical device manufacturers. Reed Tech SingleSource™ for Medical Devices, along with the quality management and regulatory expertise of Greenlight Guru helps manufacturers in implementing best practices. With world-class workflow solutions, QA/RA professionals around the world benefit from superior, end-to-end traceability and quality standards to streamline efficiency, reduce risk and meet the compliance requirements of local health authorities," said Arshad Rahman, General Manager of the Reed Tech Life Sciences division.
"Greenlight Guru is pleased to have an industry-leading UDI submission answer to solve for this step in the regulatory process. Reed Tech is a core UDI submission provider for many manufacturers around the world, large and small. Our customers can benefit from their specialized understanding of regulatory submission requirements for medical device manufacturers," said David DeRam, CEO of Greenlight Guru. Manufacturers bringing new products to market or maintaining existing portfolios will benefit from the subject-matter expertise offered by Reed Tech."
Medical device manufacturers and labelers are continually upgrading processes and preparing for multiple global health authority requirements. The complementary solutions and services between Reed Tech and Greenlight Guru offer critical efficiency gains in managing the product life cycle.
About LexisNexis Legal & Professional
LexisNexis Legal & Professional® is a leading global provider of legal, regulatory, and business information and analytics that helps customers increase productivity, improve decision-making and outcomes, and advance the rule of law around the world. As a digital pioneer, the company was the first to bring legal and business information online with its Lexis® and Nexis® services. LexisNexis Legal & Professional, which serves customers in more than 160 countries with 10,400 employees worldwide, is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers.
Reed Tech serves manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles by delivering better outcomes for the collection, transformation, submission, and analysis of regulatory data. Our solutions support the innovation ecosystem and enable you to achieve regulatory compliance and improved product data management contributing to impactful innovations to our world. The corporate mission is to advance humanity by delivering better outcomes to the innovation community. Reed Tech is a LexisNexis® company. For more information, please visit ReedTech.com.
About Greenlight Guru
Greenlight Guru is the only dedicated Medical Device Success Platform (MDSP) designed specifically for medical device companies. The platform helps companies bring safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits and more. Greenlight Guru's platform is used by thousands of organizations across the globe to push beyond baseline compliance and achieve True Quality for their medical devices. For more information, visit www.greenlight.guru/reed-tech.
Media Contact:
Angela Alexandrow
(267) 961-8018
[email protected]
SOURCE LexisNexis Reed Tech
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