The United States has the largest medical device market in the world, spending more than $150 billion dollars on medical devices each year. The medical technology industry, however, is facing ever-stricter regulatory demands and constantly growing competition, making it crucial for manufacturers to revamp their business processes and operate more efficiently to remain profitable and competitive.
FDA Compliance for Medical Device Tracking
The FDA requires manufacturers to track medical devices from assembly through distribution, which ensures that manufacturers establish tracking systems early on to enable the prompt location of a device within commercial distribution. The information is then used to facilitate notifications and/or recalls ordered by the FDA in the event that a device proves faulty or poses potential health risks.
Advanced technology systems make it possible to automate registration tracking processes, allowing medical device manufacturers to achieve greater operational performance and reduce risk.
Why Sage Enterprise Management (Sage X3) for Medical Device Tracking Software
Sage Enterprise Management was designed and developed with medical device registration and tracking in mind, with functionality including:
- Full lot and serial number traceability
- Transaction audit trails
- Quality Management
- Quality Control Status for containment
Sage Enterprise Management’s quality control management process also enforces regularly scheduled product inspections to ensure that all devices meet industry mandated specifications, operational tolerance requirements, and expected results. Companies can conduct inspections at any point in the production process, automatically isolating substandard devices for further examination or disposal. In addition, it allows for quality control status flags so production and quality associates can confirm the status of the product. Sage Enterprise Management’s rule-based system prevents the use of items that don’t meet predetermined quality standards.
Learn how the Sage Enterprise Management system for medical manufacturing can help automate your registration tracking processes while maintaining compliance standards and reducing potential risks. Contact the experts at Southeast Computer Solutions for more information.