Medical-device engineering is unusually constrained — every design decision has to be defensible against FDA / CE / regulatory review, and every change has to be tracked back to its rationale. Engineering tooling has to support traceability as a first-class concern, not as an afterthought.
DDSPLM helps device makers meet that bar without compromising on engineering velocity.
Capabilities
- Mechanical and biomechanical design in NX, with surfacing for organic geometries and sheet-metal for housings.
- Biomechanical simulation — soft-tissue contact, fluid-structure interaction, implant mechanics.
- Reliability analysis — fatigue, drop, sterilisation thermal cycles.
- Packaging validation for transit, storage, and shelf life.
- Teamcenter PLM with the configurations needed for design-history-file style traceability and compliance reporting.
Why customers pick us for this sector
We’ve supported customers building Class II and Class III devices, where the bar for design-history-file rigour is unforgiving. Our deployments are configured for the change-control discipline these programmes require — every ECO traceable to a need, every revision tied to a rationale.