Medical Plastics Machining Services with Precision CNC

Criterion Precision Machining delivers mission-critical medical plastics machining with tolerances down to ±.0002". ISO 13485 certified and FDA registered, we specialize in PEEK, Ultem, and specialty medical-grade polymers for implantable devices, surgical instruments, and diagnostic equipment. Our advanced CNC capabilities ensure biocompatibility, sterility compliance, and zero-defect manufacturing for components where failure is not an option in healthcare applications.

Precision CNC machining of medical-grade plastic components in a clean manufacturing environment

Our Medical Plastics Machining Services

Comprehensive precision CNC solutions for medical-grade plastics, from prototyping through full production with ISO 13485 compliance.

Swiss Turning for Medical Plastics

Micro-precision Swiss turning for small-diameter medical plastic components with tolerances to ±.0002". Ideal for catheter components, micro-surgical instruments, and implantable device parts requiring exceptional surface finishes and complex geometries in PEEK, Ultem, and specialty medical polymers.

Multi-Axis CNC Milling

3-, 4-, and 5-axis CNC milling for complex medical plastic components including surgical instrument housings, diagnostic equipment parts, and orthopedic device components. Precision machining of intricate features, pockets, and contours in medical-grade thermoplastics with consistent repeatability.

CNC Turning Services

High-precision CNC turning for cylindrical medical plastic parts including connector bodies, valve components, and device housings. Multi-axis capabilities for complex geometries with live tooling for secondary operations, ensuring tight tolerances and smooth surface finishes critical for medical applications.

Medical Device Prototyping

Production-intent prototyping for medical plastic components using the same equipment and quality standards as full production. Test fit, function, and biocompatibility with meaningful prototype runs that provide real-world performance data before scaling to volume manufacturing.

Quality Inspection & Documentation

ISO 13485 compliant inspection with CMM measurement, optical inspection systems, and comprehensive documentation. Includes Certificates of Conformance, material certifications, dimensional reports, and full traceability for FDA-regulated medical device components.

Tight Tolerance Machining

Ultra-precision machining capabilities achieving tolerances down to ±.0002" on medical-grade plastics. Critical for implantable components, mating parts, and assemblies requiring exact dimensional control. Advanced metrology ensures every dimension meets or exceeds specifications.

ISO 13485 Certified Excellence

Precision-Engineered Medical Plastics for Critical Healthcare Applications

When medical device manufacturers need precision-machined plastic components, they turn to Criterion. Our FDA-registered facility specializes in machining medical-grade polymers like PEEK, Ultem, and specialty plastics with tolerances to ±.0002". From implantable device components to surgical instruments and diagnostic equipment, we deliver zero-defect manufacturing backed by ISO 13485 certification and comprehensive quality documentation. Every part is produced on advanced CNC equipment with full traceability and compliance support.

Close-up of precision-machined medical PEEK plastic component with measurement tools
The Criterion Difference

Why Choose Criterion Precision Machining?

Delivering mission-critical medical plastics machining with three generations of precision manufacturing excellence.

ISO 13485 Certified

FDA-registered facility with ISO 13485 and ISO 9001 certifications ensuring full regulatory compliance for medical device manufacturing.

Micro-Precision Capabilities

Tolerances down to ±.0002" with Swiss turning capabilities for diameters as small as .010" in medical-grade plastics and specialty polymers.

Full Traceability

Comprehensive quality documentation with CMM inspection reports, material certifications, Certificates of Conformance, and complete lot traceability for regulated medical components.

Woman-Owned Heritage

Third-generation, woman-owned business (WBENC certified) with 70+ years serving 'No Failure' industries including medical devices, aerospace, and defense.

Meet Our Leadership Team

Experienced professionals dedicated to precision medical manufacturing excellence.

Professional headshot of Tanya DiSalvo, President

Tanya DiSalvo

President

As third-generation owner and President of Criterion Precision Machining, Tanya DiSalvo leads our commitment to delivering mission-critical components for Texas railroad infrastructure. Under her leadership, Criterion has evolved into a woman-owned precision machining company specializing in the 'No Failure' sectors, including railroad safety systems. Tanya's vision has guided the company's investment in advanced CNC technology and ISO certification programs, ensuring our Texas railroad clients receive components that meet the most stringent safety and performance standards. Her dedication to quality excellence and operational efficiency has positioned Criterion as a trusted partner for railroad manufacturers requiring precision components that perform reliably across Texas's diverse operating environments, from Gulf Coast humidity to West Texas desert conditions.

Professional headshot of Kelly Marflak, Quality Manager

Kelly Marflak

Quality Manager

Kelly Marflak serves as Quality Manager at Criterion Precision Machining, overseeing our comprehensive quality assurance programs critical to railroad component manufacturing. With deep expertise in precision inspection protocols, Kelly manages our certified Quality Assurance program that includes multiple points of precision inspection built into manufacturing processes. She oversees the operation of our Global Advantage CMM with PC-DMIS software, OASIS Optical Automatic Smart Inspection System, and Keyence measuring systems capable of measuring up to 99 dimensions simultaneously. Kelly's meticulous attention to detail ensures every railroad component meets the exacting tolerances and safety standards required for Texas railroad applications. Her leadership in quality control processes has been instrumental in maintaining our ISO 13485 and ISO 9001 certifications, providing railroad manufacturers with the documentation and compliance verification essential for safety-critical components operating across Texas's extensive rail network.

Professional headshot of Mike Pinchot, Estimator/Project Manager

Mike Pinchot

Estimator/Project Manager

Mike Pinchot brings extensive project management expertise to Criterion's railroad machining operations as Estimator and Project Manager. With deep understanding of precision manufacturing requirements, Mike works closely with Texas railroad clients to develop accurate project estimates and manage complex machining programs from concept through delivery. His technical expertise enables him to assess challenging railroad component specifications and coordinate multi-axis machining operations, Swiss turning processes, and quality inspection requirements. Mike's project management approach ensures railroad components are delivered on time and within budget while meeting the stringent quality standards required for safety-critical applications. His collaborative work with engineering teams and manufacturing personnel has streamlined processes for producing complex railroad parts, from prototype development through full production runs, ensuring Texas railroad infrastructure receives components manufactured to the highest precision standards.

Professional headshot of David Glass, Chief Financial Officer

David Glass

Chief Financial Officer

David Glass serves as Chief Financial Officer at Criterion Precision Machining, bringing strategic financial leadership to support our continued growth and investment in advanced manufacturing capabilities. With his comprehensive understanding of manufacturing economics and operational efficiency, David ensures that our precision machining operations remain competitive while maintaining the highest quality standards. His financial expertise enables Criterion to make strategic investments in cutting-edge CNC equipment, quality systems, and workforce development that directly benefit our clients in mission-critical industries. David's analytical approach to business management helps optimize our manufacturing processes and resource allocation, ensuring we can deliver exceptional value to customers while maintaining the financial stability necessary for long-term partnerships. His commitment to operational excellence supports our ability to serve the demanding requirements of medical device, aerospace, defense, and photonics manufacturers who rely on our precision machining capabilities.

Kellyanne Gottschalk, Internal Systems Manager at Criterion Precision Machining

Kellyanne Gottschalk

Internal Systems Manager

Kellyanne Gottschalk serves as Internal Systems Manager at Criterion Precision Machining, responsible for managing and optimizing the company's operational and business systems, including the ProShop ERP platform. Her role is critical in ensuring seamless workflow from order intake to final delivery, enabling real-time visibility into production scheduling, quality documentation, and compliance tracking. Kellyanne's expertise in systems management supports Criterion's ability to scale efficiently while maintaining the rigorous documentation and traceability standards required by regulated industries such as medical devices and aerospace. Her work underpins the company's operational excellence and helps ensure every project is delivered on time and in full compliance.

Nilda Feliciano, Customer Service representative at Criterion Precision Machining

Nilda Feliciano

Customer Service

Nilda Feliciano is the Customer Service representative at Criterion Precision Machining, serving as a dedicated point of contact for clients throughout the entire order lifecycle. From initial inquiries to order updates and delivery coordination, Nilda ensures that every client receives responsive, clear, and professional communication. Her commitment to customer satisfaction reflects Criterion's values of reliability and partnership, particularly important for clients in time-sensitive industries like aerospace, defense, and medical devices. Nilda's friendly and knowledgeable approach helps build lasting relationships with customers, ensuring they feel supported and informed at every stage of their project with Criterion.

Bonnie Paletta, Office Administrator at Criterion Precision Machining

Bonnie Paletta

Office Administrator

Bonnie Paletta serves as Office Administrator at Criterion Precision Machining, keeping the day-to-day operations of the business running smoothly. Her organizational skills and attention to detail ensure that administrative processes, documentation, and internal coordination are handled efficiently, freeing up the production and quality teams to focus on delivering precision components. Bonnie is a vital part of the Criterion team, contributing to the company's culture of professionalism and reliability. Her support role touches every department, helping to maintain the high standards of communication and organization that Criterion's clients in medical device, aerospace, and defense industries depend on.

Frequently Asked Questions

What types of medical-grade plastics can you machine with precision CNC?

Criterion specializes in machining medical-grade polymers including PEEK (polyetheretherketone), Ultem (polyetherimide), polycarbonate, acetal, and other specialty plastics approved for medical device applications. We have extensive experience with materials requiring biocompatibility, chemical resistance, and sterilization capability for implantable devices, surgical instruments, and diagnostic equipment components.

What tolerances can you achieve on medical plastic components?

Are you ISO 13485 certified and FDA registered?

Can you provide prototyping services for medical plastic components?

What size medical plastic components can you manufacture?

What quality documentation do you provide with medical plastic parts?

What is your typical lead time for medical plastic machining projects?

Do you handle secondary operations and finishing for medical plastics?

Ready to Discuss Your Medical Plastics Project?

Connect with our technical team to explore how our precision CNC capabilities can meet your medical device component requirements.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485 Certified

Medical device quality management system certification

ISO 9001 certification logo

ISO 9001 Certified

International quality management standard certification

WBENC certification logo

WBENC Certified

Women's Business Enterprise National Council member

Get a Precision Quote for Your Medical Plastics Project

Share your specifications and requirements. Our team will provide a detailed quote with timeline and technical recommendations for your medical-grade plastic components.

Contact Us Today

For immediate assistance, feel free to give us a direct call at 216-267-1733. You can also send us a quick email at office@criteriontool.com.