FDA Medical Device Molding
FDA-registered medical device molding on an ISO 9001:2015 quality system.
Precision components built inside a documented quality system, not bolted on after the fact.
Why Medical Manufacturers Choose Crestwood
Plastic injection molding is one of the most efficient, cost-effective ways to produce medical device components at the precision and quality medical applications demand. Our facility is ISO 9001:2015 certified and registered with the FDA as a medical device manufacturer, and our quality system covers incoming materials verification, in-process inspection, and finished-part validation.
That combination shows up in the parts we produce every day: engineering-grade resins molded to tolerances as tight as 2 microns, with full traceability from raw material to finished component.
Secondary Operations Included
FDA-Registered Facility
Tolerances to 2 Microns
Precision Medical Components
A Documented Quality System, Not an Afterthought
Medical device buyers know the difference between a supplier who claims quality and one who can document it. Every medical run at Crestwood is backed by incoming materials verification, in-process inspection, and finished-part validation, the same documented quality system that supports our ISO 9001:2015 certification.
- ISO 9001:2015 certified quality management system
- FDA-registered manufacturing facility
- Engineering-grade resins selected for medical-grade performance
- Tolerances to 2 microns on precision components
- Full material traceability from resin to finished part
What We Mold for the Medical Field
Frequently Asked Questions
Is Crestwood certified for medical device molding?
Yes. Crestwood Industries is an FDA-registered facility, certified to ISO 9001:2015, with a documented quality system built for medical device component manufacturing.
What is the difference between FDA-registered and FDA-approved?
FDA registration means the facility is on file with the FDA and subject to its regulations. The FDA does not approve manufacturers directly, it registers facilities and, separately, clears or approves specific devices. Crestwood is an FDA-registered facility.
What tolerances can Crestwood hold on medical components?
Our automated, microprocessor-controlled presses hold tolerances as tight as 2 microns, meeting the precision medical device components require.
Building a Medical Device Program?
Tell us about your component and we will walk you through our ISO 9001:2015 quality system and capabilities.
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