FARMINGDALE, NY (08-25-08): EtQ is pleased to announce the implementation of its Quality Management System (QMS) at NeuroPace - designers, developers, and manufacturers of implantable devices for the treatment of neurological disorders by responsive brain stimulation.
NeuroPace recognized the need for a QMS that would streamline their processes and increase quality and compliance throughout their organization, and chose EtQ Reliance for Medical Device - an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Medical Device industry, and exceed GMP and 21 CFR Part 11 software requirements.
"EtQ's unique modular approach with its FDA compliance software will provide NeuroPace with unparalleled flexibility and automation," states Glenn McCarty, Chief Executive Officer of EtQ. "Our modules, such as Complaint Handling and Validation, are tightly integrated in order to deliver a best-in-class FDA Management Software solution to all of our customers."
We at EtQ look forward to meeting all of NeuroPace's medical device needs and are pleased to be able to provide NeuroPace with a flexible FDA compliance management system.
NeuroPace was founded to design, develop, manufacture, and market implantable devices for the treatment of neurological disorders by responsive brain stimulation. The company's initial focus is the treatment of epilepsy, a debilitating neurological disorder affecting approximately one percent of the population worldwide. Patients are currently being enrolled in a clinical trial of the company's RNS™ System for treating medically refractory epilepsy. Located in Mountain View, California, NeuroPace is a privately-held company with approximately 80 employees.
EtQ is the leading Enterprise Quality and Compliance Management Software for identifying, mitigating, and preventing high-risk events through integration, automation, and collaboration. EtQ uses best-in-class, integrated modules and enterprise application integration to manage and measure quality and compliance processes and execute organizational change. Key modules within the product include: Document Control, CAPA (Corrective and Preventive Action), Audit Software, Complaint Handling, Risk Management, Change Management, Employee Training, Project Management, Nonconforming Materials, Enterprise Reporting, and more than 20 additional compliance-oriented modules. With its world-class flexible workflow, collaborative platform, EtQ has developed a unique niche to support enterprises involved in various compliance management initiatives such as; cGxP (FDA), ISO 13485, ISO 9001:2008, ISO/TS 16949, ISO 14001, ISO 22000, AS 9001, TL 9000, OHSAS 18001, RoHS, Sarbanes-Oxley, HACCP, SQF and similar standards for compliance and regulatory management. EtQ has been providing compliance solutions to a variety of markets for over 15 years.
EtQ is a trademark of EtQ Management Consultants, Inc. All other product names and company names are trademarks or registered trademarks of their respective owners.