Quality is at the core of our business. We are passionate about quality employees and their perspectives, the quality partnerships we have with our customers, the quality products we manufacturer, and the Quality Management System we have put in place. We take quality so seriously that we recognize we may not always be the right choice for every customer and every product. Contact our Director of Regulatory & Quality, David Smith, to discuss your next quality project.

Quality Highlights

ISO 13485 Certified

ISO 14971 Compliant

FDA Registered and Compliant

Equipment Validations EIQ/EOQ

Passivation Process Validated

Cleaning Process Validated

JobBoss/E2 ERP-QMS system

PFMEA

DOE

Inspection and/or Control plans

JobBoss/E2 ERP-QMS system

Quality Policy

Ngage Medical believes quality is consistently providing products which meet customer expectations. We accomplish this by monitoring and continually improving the effectiveness of the quality management system to meet customer’s expectations through innovation and compliance with applicable standards and regulations.


ISO 13485 Certificate >