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Oracle is sunsetting Agile PLM in 2027. Your migration window is open.
Medical device manufacturers on Agile PLM face end-of-life risk, compliance gaps, and scalability walls. IndX delivers a structured, validated migration path to Siemens Teamcenter, designed for regulated device development from the ground up.
Oracle's end-of-life announcement is the catalyst, but the real problems have been building for years. Agile PLM was never designed for where medical device compliance stands today.
No new regulatory updates. No security patches. No compliance fixes. Every month after EOL compounds exposure across FDA 21 CFR, EU MDR, and ISO 13485.
Oracle EOL ConfirmedAgile PLM lacks native depth for DHF, DMR, UDI labeling, ISO 14971 risk management, and modern audit trail requirements. Rigid workflows force workarounds, and workarounds create audit findings.
Regulatory ExposureLarge BOMs strain Agile PLM's architecture. Every integration with ERP, CAD, or QMS requires expensive custom development that you rebuild every time the underlying systems change.
High TCO
Teamcenter isn't a generic PLM repackaged for medtech. It's a platform designed around the traceability depth, compliance frameworks, and change management complexity that medical device manufacturers operate under.
Built-in frameworks for DHF, DMR, UDI, ISO 14971, and 21 CFR Part 11. Audit-ready from day one, not bolted on after implementation.
End-to-end traceability from requirements through design, risk, testing, and post-market surveillance. One unified audit trail, no gaps.
Teamcenter X SaaS delivers continuous compliance updates with zero infrastructure burden. On-premises where data sovereignty requires it.
Native connectors to SAP, SolidWorks, NX, Creo, Polarion, eQMS, and MES. No custom middleware, no brittle point-to-point integrations.
CAPA, NC tracking, and quality workflows built directly into the PLM layer. Quality and product data live together, not in disconnected silos.
Configurable ECO, ECN, and design review workflows adapted to your regulatory model. Multi-BOM at enterprise scale with role-based UX.
A direct comparison across the dimensions that matter most for medical device manufacturers navigating end-of-life and growing regulatory complexity.
Measurable performance improvements medical device manufacturers see when they migrate from Agile PLM to Siemens Teamcenter with IndX.
Design History File and Device Master Record preparation takes a quarter fewer hours, directly compressing regulatory submission cycles.
Reduction in FDA findings attributed to traceability gaps. Full traceability from requirements to audit leaves nowhere for gaps to hide.
Accelerated product launch cycles through improved change management and eliminating manual documentation bottlenecks.
SaaS cloud delivery eliminates infrastructure overhead and the maintenance burden of a fragile custom integration stack.
Across R&D, RA/QA, and Manufacturing, from unified BOM management, automated workflows, and role-based access to live product data.
Closed-loop quality management and enhanced traceability reduce product lifecycle risk, quantifiable in audit outcomes.
IndX's migration methodology de-risks every step, with 21 CFR Part 11 validation, ERP and CAD integration, and dedicated hypercare built in from the start.
Evaluate existing Agile PLM modules, customizations, and data volume. Map regulatory requirements and integration landscape.
KickoffMap workflows to Teamcenter architecture. Build regulatory templates and BOM structures. Execute legacy data migration with full validation.
Core BuildIntegrate ERP, CAD, and QMS. Execute 21 CFR Part 11 validation. Configure UDI and labeling compliance. Full UAT with all stakeholders.
ValidationRole-based training and cutover. Production system launch with dedicated triage support. Post-go-live hypercare to drive adoption.
ProductionManaging complex product programs with multi-variant BOMs, CAD integration, and design change control in a system that wasn't built for your scale. Teamcenter solves this at the architecture level.
Spending too much time on audit prep, DHF compilation, and chasing traceability manually. Teamcenter puts regulatory compliance in the product record, not the spreadsheet.
Maintaining a fragile integration stack between Agile PLM, SAP, and your QMS that won't survive 2027. IndX builds integration architectures that don't require a full-time babysitter.
IndX combines Teamcenter implementation expertise, regulated manufacturing context, and a structured migration-led approach that helps companies move faster and with less risk than a generic rip-and-replace project.
Deep product expertise in Teamcenter, Teamcenter X, and the full Siemens PLM stack. Not a generic IT integrator learning on your dime.
Proven experience with FDA 21 CFR Part 11, EU MDR, ISO 13485, and ISO 14971. We know the regulatory landscape your products live in.
Data cleansing scripts, workflow mapping templates, and validation accelerators that compress your timeline and reduce migration risk.
IndX doesn't hand you a PowerPoint and leave. We design, implement, integrate, validate, and support you through hypercare and beyond.
