Delivering Traceability, Quality and Change Control for Medical Devices

From Design Control to Batch Release

Medical device manufacturing operates under constant regulatory pressure. Design changes, supplier substitutions, and production deviations are unavoidable - and each introduces compliance, quality, and patient safety risk if not tightly controlled.

In many organizations, design control, manufacturing execution, and quality data live in separate systems. Changes approved in Teamcenter can take days to reach production systems like Opcenter, creating gaps where devices are built against outdated data.

The result is slower investigations, stalled CAPAs, and audits that require manual reconstruction of device history. Supplier changes compound this risk when lot- and serial-level traceability is incomplete.
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How IndX Helps Medical Device Manufacturers

IndX connects design, manufacturing, and quality data into a continuous digital thread so approved changes flow cleanly into production. Every device, lot, and batch remains traceable to approved design intent.

This reduces manual reconciliation, shortens investigation and CAPA cycles, and improves audit readiness - without slowing execution as products and regulations evolve.
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We Deliver Results. Not Just Compliance Checklists.

• Faster engineering change approvals without audit risk
• Reduced investigation and CAPA cycle times
• Improved audit readiness with complete digital traceability
• Lower risk of batch release delays

Delivered in live, regulated manufacturing environments.
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Built to Deliver Outcomes Across the Product Lifecycle

IndX helps medical device manufacturers:

• Maintain design control across frequent changes
• Reduce compliance risk without slowing innovation
• Improve batch and device-level traceability
• Scale operations while staying audit-ready