Medical Device Quality Management System
Medical Device Quality Management System
Tietronix provides a web-based quality management software application that helps manage the life cycle of medical device products. This QMS application makes it easy to adhere to FDA regulations and compliance standards through built-in processes. Development teams are guided through each detailed task from concept to implementation with regulatory
compliance and standards mapped into each process step.
Our quality management system, Medical Device Accelerator (MDA), provides the infrastructure that enables significant efficiencies and productivity gains and can reduce the key risks when bringing medical devices successfully to market. MDA achieves this through work-flow automation as part of an enterprise suite of tools.
Document Management - Electronic Document Management/Electronic Documentation System, Electronic Signature/E-signature, Review boards, Document Change Requests, Automatic Notifications, Document TrainingLibrary - Process Library, Design control process, Risk analysis process, Customizable processes, Repeatability, Document templatesDatabase - Mapping of compliant standards, Archive of changed documents, Audit trails, Query reports, Electronic Design History File (DHF)Project Management - Project Lifecycle Management (PLM) - Easy adherence to FDA design controls, Corrective and Preventative Actions (CAPA), Defect tracking, Objective evidence, Project Transparency, Real-time notifications


