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.
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. Leverage the Epicor Life Sciences Cloud infrastructure to support software validation and continued compliance.
Unlock possibilities for your rapid growth and improve business momentum with streamlined capabilities for the complex needs of medical device manufacturers. Kinetic ERP solutions are based on ‘always current’ methodology that supports your operations with the latest technology through regular updates on a deferred cadence that supports compliance requirements.
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 BrochureMedical devices must comply with stringent regulations like those from the FDA and EMA. ERP systems help ensure compliance, track changes, and support audits and recalls. Regulatory demands on software validation often hinder tech updates, but Epicor provides cloud solutions with regular upgrades on a deferred cadence to maintain compliance without foregoing necessary updates.
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.
Sophisticated Enterprise Content Management for document control and process automation
Regulatory 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 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.
