ISO 13485:2003 • FDA Registered

Quality Assurance


Our company assures customer satisfaction and product safety through a robust and proven Quality Management System (QMS) that is 21 CFR 820 FDA Quality System Regulation compliant and certified to ISO 13485. Our comprehensive quality management system encompasses the essential elements necessary for the design, production and distribution of innovative medical devices to meet today’s healthcare and cost containment needs.  Nexcore’s QMS is suitable for Class III medical devices and is applicable to all classes of medical products by controlling and defining product design, monitoring production processes and nonconforming product, and instituting corrective and preventive actions, when necessary.  Our QA operation involves continually monitoring quality control and quality assurance processes, operating procedures and other quality records to provide reliable products and effective services to fully satisfy our customer needs and expectations.

FDA Registration

Nexcore Technology Inc. is registered with the US FDA under establishment number is 3007199740.

ISO 13485 Certification

Nexcore Technology maintains a certification for ISO 13485 for medical devices.  Our certificate is issued by Lloyd’s Register Quality Assurance Inc.

Nexcore Technology, LLC
150 Hopper Avenue • Waldwick NJ, 07463 • 201-968-9400 •
©2018 Nexcore Technology, LLC