NORTHBROOK, Ill., May 29, 2015– Today, UL LLC, a global safety science organization and MasterControl, a leading global provider of electronic quality management systems (EQMS) and quality consulting services, announce a collaborative agreement which will leverage the strengths of both organizations to support the medical industry with both quality system implementation and comprehensive advice and guidance for successful global regulatory submissions.
Adding MasterControl’s EQMS capabilities to UL’s strength in regulatory services and testing offers the medical industry a team of experts in critical areas and ultimately supports safer products in the marketplace.
“Our collaboration with MasterControl is founded on our mutual commitment to help medical device manufacturers get the products to the people who need them,” said Deborah Jennings-Conner, director of Global Operations for UL’s Health Sciences Division. “These types of arrangements allow us to become an even closer partner with both the manufacturers of healthcare products as well as product regulators.”
Device manufacturers are required to demonstrate compliance under regulations in every country where their products are used. The MasterControl-UL collaboration aims to help these manufacturers understand the various requirements for clinical and non-clinical testing in each country, and help them manage the documentation needed to support evidence of training, complaints, corrective and preventative action and more.
“UL brings extensive experience that represents a significant benefit to MasterControl and our global expansion efforts,” said Michael Bothe, MasterControl senior vice president of Sales and Partner Operations. “UL’s strategic approach to regulatory compliance goes hand-in-hand with MasterControl’s quality management directives.”
UL is a premier global independent safety science company that has championed progress for more than 120 years. Its nearly 11,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, testing, inspection, advisory and education services, visit https://www.ul.com/.
MasterControl Inc. produces software solutions that enable companies doing business in regulatory environments to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. MasterControl software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions include quality management, document management/document control, product lifecycle management, audit management, training management, bill of materials, supplier management, submissions document management, clinical management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides customers with a complete information management solution across the entire enterprise. For more information about MasterControl, visit www.mastercontrol.com, or call: 800-825-9117 (U.S.); +44 (0) 1256 325 949 (Europe); or 81 (3) 5422 6665 (Japan).