Quality Management & Compliance for Medical Device Manufacturing

The AssurX complaints management and regulatory reporting system provide the ‘best practice’ approach for managing the entire lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies. It features include best practice matrixes, management dashboards, and strong audit trail reports and controls.

Globally document, track, and resolve manufacturing related quality issues such as nonconformance, deviations, defects, incidents, exceptions, and change requests, from initiation through disposition, corrective action and change execution. This closed-loop system is fully integrated with other quality and compliance processes and follows ISO and GMP standards for best practices. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiency.

Take charge of all training requirements, activities, materials/courses and histories throughout your organization. Quickly identify “who-needs-what” training even in complex, changing environments. The AssurX solution ensures your personnel are always effectively trained for the job, all training is properly documented and training histories are accessible, auditable and correctly reported when necessary.

The entire MedWatch 3500A process is pre-built and ready to use out of the box. Simply enter the medical device company’s manufacturing ID and general default values such as address information to get started. No additional configuration is needed—users can start using the process and submitting to the FDA. For medical devices companies, eMDR (electronic medical device reporting) is fully integrated, allowing MedWatch 3500A and other vigilance reports to be generated and submitted directly from the system.

Improve customer satisfaction and retention by quickly resolving product quality issues reported by customers in a thorough, consistent and predictable manner. Quality issues from customer related sources are logged and investigated. Root causes identified, and corrective/preventive actions are launched across operations, and then checked for effectiveness. Includes management of complaints, issues arising from field service events, incoming calls, and product returns.

AssurX’s SQM solution offers instant collaboration and visibility across your supplier network to vastly improve product quality. No matter the number or location of your suppliers and contract manufacturers, SQM lets you quickly detect, inspect, track, trend and contain supplier related quality issues quickly and correct them before they become bigger issues.