Trusted Orthopedic Implant Contract Manufacturing Services

Criterion Precision Machining provides Orthopedic Implant Contract Manufacturing Services for OEMs that need exacting tolerances, compliant documentation, and dependable production continuity. From prototype-intent runs through repeatable CNC, Swiss turning, UDI laser marking, finishing, and inspection, our ISO 13485-certified team supports implantable device components where material traceability, dimensional accuracy, and process control are critical.

Orthopedic implant components manufactured with precision CNC machining

Our Orthopedic Implant Contract Manufacturing Services

Contract manufacturing capabilities for orthopedic implant components, from prototypes to documented, repeatable production.

Medical Machining

ISO 13485-supported machining for surgical instruments, implantable device components, orthopedic fasteners, and diagnostic equipment parts requiring tight tolerances, traceable materials, compliant documentation, and reliable repeatability.

CNC Milling

Advanced 3-, 4-, and 5-axis CNC milling produces complex implant geometries, fine features, tight pockets, and close-tolerance components from titanium, stainless steels, specialty plastics, alloys, and exotic materials.

Swiss Turning

Multi-axis Swiss turning supports small-diameter orthopedic fasteners, surgical pins, and intricate implantable device components with diameters as small as .010 inches and tolerances down to ±0.0002 inches.

CNC Turning

Precision CNC turning creates cylindrical and complex medical components with smooth finishes, live-tooling efficiency, reduced setup variation, and repeatable production for micro- to medium-sized implant parts.

Quality Inspection

Integrated quality assurance includes incoming material verification, FAI/FAIR, in-process inspection, final inspection, Certificates of Conformance, material traceability, CMM inspection, and optical measurement documentation.

Laser Marking

In-house fiber laser marking provides permanent serialization, UDI marks, lot numbers, 2D matrix codes, logos, and identification on titanium, stainless steel, aluminum, alloys, and selected plastics.

Precision machining inspection for orthopedic implant components

Our 5-Step Manufacturing Process

Engineering Review And Planning

Our team reviews drawings, models, materials, tolerance requirements, volumes, and regulatory documentation needs. We assess manufacturability early, identifying risk points such as micro-features, implant-grade materials, finishing expectations, and inspection requirements before production planning begins.

Production-Intent Prototype Runs

Precision Machining And Finishing

Certified Inspection And Documentation

Traceable Delivery And Support

The Criterion Difference

Why Choose Criterion Precision Machining?

A contract manufacturing partner built for components where failure is not an option.

Certified Quality

ISO 13485 and ISO 9001 systems support regulated orthopedic implant manufacturing requirements.

In-House Control

CNC, Swiss, 5-axis milling, finishing, marking, and inspection remain under one roof.

Tight Tolerances

Capabilities reach ±0.0002 inches for complex, micro-sized, and high-repeatability components.

Proven Legacy

Founded in 1953, Criterion supports demanding “No Failure” sectors with proven discipline.

Meet The Criterion Team

Experienced leadership for mission-critical manufacturing programs.

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 is orthopedic implant contract manufacturing?

Orthopedic implant contract manufacturing typically includes production-intent prototyping, CNC milling, Swiss turning, CNC turning, finishing, laser marking, inspection, and documentation. Criterion Precision Machining supports implantable device components, orthopedic fasteners, surgical instruments, and diagnostic equipment parts with ISO 13485 quality systems, material traceability, FAIRs, Certificates of Conformance, and in-house metrology for regulated medical device programs.

What materials are used for orthopedic implant components?

Is Criterion Precision Machining certified for medical device manufacturing?

How tight can your tolerances be for implant components?

Can you support prototype-to-production implant programs?

Do you provide UDI laser marking and serialization?

What quality documentation is included with implant manufacturing?

How do I request a quote for orthopedic implant machining?

Need Help With Specifications?

Connect with our team about your implant manufacturing requirements.

Certified & Trusted

Awards and Recognition

ISO 13485 certification badge

ISO 13485

Medical device quality system certification.

FDA registered manufacturing badge

FDA Registered

FDA registration supporting regulated manufacturing.

ISO 9001 certification badge

ISO 9001

Certified quality management for precision machining.

Start Your Implant Manufacturing Program

Share your drawings, specifications, materials, and production requirements. Our team will review tolerances, compliance needs, manufacturability, documentation, and next steps for your orthopedic implant program.

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.