Maintaining the highest quality levels, and a strict state of control and regulatory compliance not only affects the bottom line, it can literally be matters of life and death for medical device manufacturers.
In addition to the FDA’s stringent device regulation requirements, medical device manufacturing companies also face serious regulatory scrutiny from the Department of HHS and its HIPAA patient privacy regulations. It is incumbent upon medical device manufacturers to use software, hardware, and system processes that ensure only those personnel required to see a given piece of data are in fact allowed to access it.
AssurX medical device QMS software is designed with global quality management and medical device regulatory requirements in mind. Successful companies use AssurX’s seamlessly integrated software to centrally monitor, manage and improve their quality and regulatory compliance related processes across all operations.
The AssurX platform provides an end-to-end, flexible system for managing quality and regulatory compliance.
In addition, AssurX provides pre-configured solutions that create closed-loop solutions deliver FDA 21 CFR Part 11 compliant processes to manage complaints, supplier quality, document control, CAPA, change, audits, and training. A state of control and proof of compliance is maintained continuously in one central, securely accessible system.
The AssurX software is validated and comes with IQ/OQ validation templates. Each pre-configured solution comes with a PQ based on industry best practices and the latest regulatory guidelines.
AssurX quality management system software is designed to support requirements and standards for the FDA regulated medical device manufacturing industry. The solutions seamlessly integrate, creating an ironclad closed-loop system to identify, track, resolve, document and report all quality and compliance issues across every part of operations—even into the supply chain.
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