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QMS - Quality Management System

Challenge: Manage the life cycle of medical device products; adhere to FDA regulations and compliance standards.

The Medical Device Accelerator provides a repeatable development process, which is key to quality, regulatory compliance, and efficiency.  Medical Device Accelerator (MDA) is a web based design control automation tool for developing and managing the medical device lifecycle.  MDA provides version control for all documents, a record of who created each revision, creation date, and any comments associated with each revision. MDA displays instructions for performing each activity and displays a graphical view of the process that is color coded to visually indicate the status. Each activity can be mapped to one or more standard and regulatory requirements (FDA Design Controls, ISO 13485, ISO 14971, IEC 62304 etc.) for compliance reporting.