Medical Devices ERP

Improve Compliance and Traceability for Medical Device Manufacturing

Reduce risk and meet the rigorous quality standards of the medical devices industry. DELMIAWorks ERP provides integrated tools to manage compliance with quality across your business.

Quality Standards

Streamline Accreditation with Built-In Quality Standards

Comply with industry quality standards integrated into your ERP. DELMIAWorks includes industry-specific modules that address ISO 13485 and 9001 standards, Current Good Manufacturing Practice (CGMP) and CFR and FDA requirements.

Female uses tablet to asset quality standards of medical device production line

Product Lifecycle Management

Gain More Control over Product and Process Quality

Track products or parts through all production stages with accurate and timely reporting. DELMIAWorks ERP allows you to trace goods from concept and design to testing and manufacturing.

Female worker uses manufacturing ERP system to review product lifecycle management process for medical devices using computer

RealTime Integration

Adjust to Unplanned Events with Real-Time Updates

Ensure your plans align with the latest information from your sales orders and supply chain. DELMIAWorks ERP provides flexible scheduling and real-time integration across your business.

Worker in lab coat assess factory production line to revview the real-time integration of software in the medical device component factory

DELMIAWorks Manufacturing ERP

Integrated ERP Software for the Medical Devices Industry

Harness DELMIAWorks ERP software tailored to meet the challenges of medical device manufacturing.

Device History Record

Automate collection of the production history of medical devices and eliminate paper documents.

Corrective Action/Preventive Action (CAPA)

Identify problems and non-conformance issues, establish the root cause and create a resolution action plan.

Tools for ISO 9001 & 13485 standards

Industry-specific modules to help you achieve compliance with regulatory standards.

Secure Electronic Signature

Collect and manage electronic signatures to comply with 21 CFR Part 11.

Document Control

Rely on a secure, centralised document repository to control all documents, including standards.

Regulatory and Compliance Reporting

View custom and standard reporting options, including Recall and Analysis and product/device histories.

Data Collaboration

Share critical data with customers by enabling them to instantly print detailed tracking reports.

Material Review Board

Track and maintain all non-conformances with detailed audit trails for raw materials, work in progress and finished goods.

Speak to an Expert

Achieve More Control and Accuracy

Discover how you can benefit from a manufacturing ERP designed around the needs of the medical devices industry. Speak to one of our ERP specialists to learn more.

Frequently Asked Questions

DELMIAWorks ERP software includes multiple pre-defined BOMs that help you improve the accuracy of your production planning and scheduling.

Our team is 100% dedicated to helping manufacturers of all sizes across multiple industries, including medical devices. We have shop floor experience as production planners and expertise in just-in-time manufacturing processes, so we understand your challenges.

Yes, DELMIAWorks ERP has a specific outsourcing module to manage material movement to subcontractors and receipts following completion of the process. DELMIAWorks also handles the PO and invoicing process.

Yes, the ERP software includes tools that help you meet quality standards demanded by highly regulated industries and individual customers.