Fresenius Medical Care

Location: Waltham, MA
Industry: Medical Device
Service: Integration and AttributeState


the challenge

Fresenius Medical was a long-time Agile PLM user, but the company managed all its material compliance data outside the PLM system with a completely manual approach.

This manual material compliance process didn’t scale well. It was hindering the company’s rapid growth, forcing it to look into hiring additional headcount solely for the administrative task of tracking the data.

Fresenius was reluctant to invest money in another Agile module when Oracle considers Agile PLM to be end of life.


zws solution

ZWS implemented a complete compliance management solution in Agile PLM using the PLM system-agnostic roll-up engine extension to  AttributeState. This solution currently provides support for RoHS, REACH, Prop 65 and CMR/CLP.

ZWS also created an integration between the compliance solution in Agile PLM and Total Parts Plus (a Parts Data Content Provider) to automatically pull compliance information from manufacturers for their parts into the PLM system and roll up the compliance states throughout AMLs and BOMs by revision.

Change processes check parts for compliance and warn about or block the release of changes that will result in a regression of compliance.


the benefits

A small Fresenius staff can now handle the compliance requirements for all Fresenius’ parts and products. Data collection is fully automated and manual processes are no longer a roadblock.

The improved system is scalable no matter how Fresenius grows.

In turn, Fresenius has been freed to perform higher level quality assessments and surveys.