UL Joins MasterControl to Assist Device Manufacturers with Quality Implementation

By CIOReview | Thursday, June 18, 2015

NORTHBROOK, IL: To ensure better standards and safety in the medical industry, UL a science company and MasterControl, a provider of electronic quality management systems (eQMS) have entered a collaborative agreement to assist device manufacturers with quality implementation and guidance for successful global regulatory submissions.

Quality is the most important parameter for the overall development of any industry according to assigned set of standards to maintain and improve an industry constantly. A quality management system (QMS) is a collection of business processes focused on achieving quality policy and objectives to meet customer requirements. It is the organizational structure, policies, procedures, processes and resources needed for quality categorization. Quality system requirements for medical devices have been recognized as a way to assure product safety, efficacy and customer satisfaction

MasterControl’s EQMS will be added to UL’s regulatory and testing services to provide safer products in the marketplace. Manufacturers of devices in the healthcare industry are required to follow certain compliance rules and safety regulations which are different and specific in each country. The association of the two companies will help manufacturers understand the requirements for clinical and non-clinical testing.

The mutual partnership will help in management of documentation that supports evidence of corrective and preventive action, training and complaints.

"UL's strategic approach to regulatory compliance goes hand-in-hand with MasterControl's quality management directives.” says Michael Bothe, Senior VP, Sales and Partner Operations, MasterControl.

"Our collaboration with MasterControl is founded on our mutual commitment to help medical device manufacturers get the products to the people who need them," adds Deborah Jennings-Conner, Director, Global Operations, UL Health Sciences Division.