Accelerate digital transformation in Medical Devices

Manufacturers of medical devices operate under the strictest regulations in the world. ISO 13485, FDA QMSR (as of February 2026), 21 CFR Part 11, and EU MDR require validated processes, audit trails, and complete traceability. Infor CloudSuite is industry-specific for medical devices.

Your challenges

• Strict regulations and validation. Validated processes, audit trails, and electronic signatures are a requirement.
• Cradle-to-grave traceability and UDI. Every device uniquely identifiable (UDI-DI/UDI-PI), with DHR and DMR.
• Rigorous change control. Every change processed via formal change requests, impact assessments, and revalidation.
• Innovation speed versus regulation. Short post-launch product life cycles clash with conservative regulations.
• Pressure on cost and sustainability. Hospitals demand recyclable packaging and PCR content at lower prices.

Our industry-specific solution

Xibis delivers an industry-specific, validatable environment for medical device manufacturers with Infor CloudSuite:

• Cradle-to-grave traceability and UDI. Lot and serial tracking including UDI-DI/UDI-PI, recall scenarios executable in minutes.
• Electronic DHR and DMR. Automated Device History Records with electronic signatures, compliant with 21 CFR Part 11.
• Change control and validation as standard. Engineering change requests and revalidation workflows as core processes, not add-ons.
• Integrated quality management. NCR, CAPA, supplier quality, and post-market surveillance on the same data as production.
• Ready for FDA QMSR and EU MDR. One set of processes for both FDA and notified body audits in the EU.

Why Xibis

• Industry-specific for medical devices. Compliance, validation, and traceability are embedded, not bolted on.
• Experience with validated implementations. We understand what IQ/OQ/PQ validation means for your ERP journey.
• International regulatory coverage. FDA, EU MDR, MHRA, and PMDA on one platform.