Unify your business with Kinetic, a complete cloud ERP for medical device manufacturers.
Helping you scale to match the growth of your business requires operational controls that optimize productivity and efficiency, while maintaining high standards for traceability and compliance. Epicor Kinetic offers a complete solution designed to meet your needs.
Solutions Tailored for Medical Devices
Overcome the obstacles of point solutions with integrated medical device ERP software that handles your business’s growth and digital transformation needs—in a single platform.
Reduce your noncompliance risks with validation services, product traceability, and quality control expertise including FDA CFR 21 Part 11 and EU Annex 11.
Unlock possibilities for your rapid growth and improve business momentum with streamlined capabilities for the complex needs of medical device manufacturers.
Epicor understands the challenges with compliance faced by manufacturers in Life Sciences and has teamed up with industry experts to streamline software validation for the initial go-live as well as establish a comprehensive software validation process for ongoing management. Coordinating with Epicor's proven software validation partner, IZiel Healthcare offers a thorough program to quickly and effectively meet regulatory requirements, while helping to establish a sustainable path to support compliance with annual software upgrades.
Download BrochureRegulatory requirements around software validation can make it difficult for manufacturers to access current technology and maintain up-to-date systems. Epicor offers flexible cloud solutions with upgrade cadences, supporting compliance with software validation without having to sacrifice regular updates.
Medical devices are subjected to strict regulatory standards, like those set by the FDA (U.S. Food and Drug Administration) or EMA (European Medicines Agency). An ERP can ensure adherence to these standards, track changes, and facilitate audits.
It's crucial for medical device manufacturers to trace each product back to its source materials. A capable ERP system allows for end-to-end traceability, from raw materials to the finished product delivered to the end customer.
Medical device manufacturers often need to interface with other systems, like CRM (Customer Relationship Management) tools or specialized quality management systems. Epicor’s robust API, Data Fabric & integrations solutions deliver seamless integrations between systems.
Ensuring that devices meet consistent quality standards is paramount. ERPs can integrate quality checks, monitor quality metrics, and trigger actions if anomalies are detected. Complaints handling by advanced quality management adds another level of service and accountability.
Learn how Epicor helps medical device manufacturers with their unique set of challenges.
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