Industries: Medical

Clean Room.
Documented.
On Spec.

We supply medical device manufacturers across Iowa and the Midwest with USP Class VI and ISO 10993-compliant resins. Lot traceability, certificate of conformance, and material documentation on every order. No minimum to qualify.

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Material Challenges

What Medical Manufacturers Need to Get Right.

Regulatory Documentation

FDA and ISO 13485 audits require complete material traceability. We maintain lot-level documentation and can produce CoC, CoA, and SDS on demand - so your supplier file is complete before your next audit date, not assembled under deadline.

Biocompatibility Confirmation

USP Class VI and ISO 10993 compliance are non-negotiable in medical device supply chains. We pre-screen grades against your application requirements and can provide supporting documentation with the quote - not as a two-week follow-up after you've already committed to a program.

Grade Consistency Across Lots

Lot-to-lot variation in melt flow and color can fail a qualification. We source from manufacturers with documented process consistency and flag any lot deviation before it ships to your dock.

Short-Run Minimums

Small-volume medical programs get shut out by national distributors with 10,000-lb minimums. We have no order minimum. Qualified grades are available in the quantity your production schedule actually requires.

Material Capability

Grades We Supply for Medical.

Material	Grade Type	Key Properties	Where It Fits
Polypropylene (PP) - Medical Grade	Specialty	Sterilizable, chemical resistant, USP Class VI	Syringes, IV components, packaging
HDPE - Medical Grade	Specialty	Moisture barrier, impact resistance, FDA compliant	Bottles, caps, lab consumables
Polycarbonate (PC)	Engineering	Optical clarity, heat resistance, sterilizable	Filter housings, surgical instrument handles
ABS - Medical Grade	Engineering	Impact resistance, dimensional stability, surface quality	Diagnostic device housings, equipment enclosures
PETG	Specialty	Clarity, toughness, chemical resistance	Fluid management components, packaging

Documentation Standards

Every Order Ships
with a Complete Paper Trail.

Medical supply chains can't afford reconstruction after the fact. We prepare lot-level documentation as a standard part of fulfillment - not a special request. Certificate of conformance, CoA, SDS, and biocompatibility references organized before your dock receives the pallet.

Lot traceability to manufacturer

CoA and CoC on every shipment

USP Class VI and ISO 10993 support

Case Study

Results Speak Volumes.

100%

Audit Pass Rate

Days to Full Documentation

Lots Rejected at Incoming

Medical Device / Documentation / Midwest

Full Supplier File in 3 Days, ISO Audit Passed Without a Single Finding

A Wisconsin medical device manufacturer came to us two weeks before an ISO 13485 audit with gaps in their material supplier documentation. Their incumbent resin distributor had no structured documentation process. We rebuilt the full supplier file - CoA, CoC, lot traceability, and biocompatibility references - across all active grades in three business days. The audit passed with no findings on material supplier documentation. They converted their full resin spend the following quarter.

Ready to Source Medical-Grade Resin?

Tell us the grade, the application, and the documentation your audit requires. We'll confirm availability and prepare the supplier file.

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Clean Room.Documented.On Spec.