Medical Device Injection Molding

Hi-Rel Plastics delivers ISO-certified injection molding for medical devices, diagnostics, laboratory equipment, and other precision applications. From engineering to production, we manufacture high-quality plastic components with the consistency, accuracy, and compliance your project demands.

CERTIFICATIONS & COMPLIANCE

Certified Quality You Can Trust in Every Part

ABOUT HI-REL PLASTICS & MOLDING

Medical Device Injection Molding for Critical Applications

Hi-Rel Plastics & Molding Corp. provides injection molding services for medical devices, diagnostics, laboratory equipment, and other regulated plastic components. From part evaluation and prototyping to tooling, molding, assembly, and production, we support every stage of the manufacturing process with quality and consistency.

With more than 40 years of experience, we partner with medical device manufacturers across the United States to produce complex injection molded components in ISO-certified environments for highly regulated industries.

Medical Device Injection Molding

Hi-Rel Plastics & Molding Corp. provides ISO-certified injection molding services for medical device manufacturers across the United States. We produce precision plastic components for medical devices, diagnostics, laboratory equipment, and other regulated applications where dimensional accuracy, material compliance, and production consistency are essential.

ISO-Certified Manufacturing You Can Trust

Our medical device injection molding process supports complex geometries, tight tolerances, and medical-grade material requirements for demanding applications. Backed by ISO 13485, ISO 9001:2015, and AS9100D certifications, we combine advanced molding expertise with rigorous quality systems to help ensure reliable, repeatable production.

From prototype through full-scale manufacturing, Hi-Rel partners with customers nationwide to deliver dependable medical device injection molding solutions for critical industries.

ISO-Certified Production

Manufactured to meet the strict quality and regulatory requirements of medical device applications.

Precision & Consistency

Produces repeatable, high-quality injection molded components with tight tolerances for critical medical applications.

Medical-Grade Quality

Ideal for medical devices, diagnostics, implantable components, and laboratory equipment.

Prototype to Production

Supporting low and high volume manufacturing with expert engineering from concept through delivery.

FREQUENTLY ASKED QUESTIONS

Questions About Medical Device Injection Molding? We've Got Answers

Whether you’re developing a new medical device, scaling an existing program, or evaluating injection molding partners, our team is here to help. Below are answers to common questions about our medical device injection molding capabilities and manufacturing process.

We provide injection molding, insert molding, overmolding, cleanroom molding, assembly, packaging, and secondary operations for medical devices, diagnostics, implantable components, and other precision plastic parts.

Yes. Hi-Rel Plastics is certified to ISO 13485, ISO 9001:2015, and AS9100D, supporting medical, aerospace, defense, and other quality-critical manufacturing programs.

Yes. We operate ISO-certified cleanroom environments for injection molding and assembly of medical devices and other regulated components that require contamination control.

Yes. Our engineering team and quality systems are designed to consistently produce precision plastic components that meet demanding dimensional and performance requirements for medical device applications.

Yes. We support medical device projects from part evaluation and prototyping through mold design, tooling, production, and assembly to help streamline development and time to market.

We process a wide range of engineering and medical-grade thermoplastics, including materials that meet FDA and biocompatibility requirements. Our team can help recommend the right material based on your application's performance and regulatory needs.

Production timelines vary based on part complexity, tooling, materials, and order volume. Our team will provide a detailed schedule during the quoting process.

To begin, contact our team with your project details, including CAD files or drawings, material requirements, estimated quantities, and application information. We'll review your project and prepare a detailed quote.

Minimum order quantities depend on the manufacturing process, material selection, and project requirements. Contact us to discuss the best production plan for your medical device application.

Yes. In addition to injection molding, Hi-Rel offers cleanroom assembly and value-added secondary services to help simplify your supply chain and reduce production steps.

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