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."