PFAS Transition Engineering for a MedTech OEM 10,000+ parts triaged. 90%+ compliance. Zero regulatory holds at EU launch.
Supplier declarations said the BOM was clean. The material evidence said otherwise.
- 10,000+ parts triaged, establishing component level PFAS visibility across plastics, elastomers, tubing, coatings and gaskets
- Compliance lifted from an 85% RoHS and REACH baseline to 90%+, integrated into the existing compliance spine
- ~30% of non-compliant MRI components reworked before launch, cutting redesign risk across gaskets, seals and membranes
- 144 assemblies and 10,500 unique parts assessed, grouped by SVHC type and geography for structured SCIP submissions
- Zero regulatory holds at EU launch, with compliance, redesign and validation evidence aligned ahead of clearance review
- A reusable compliance fabric created across RoHS, REACH, SCIP, Prop 65 and PFAS for the next regulation
Download the case study to see how this OEM moved from supplier declarations to submission ready PFAS evidence, and launched in the EU without a single hold.
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