Medical Precision Machining Parts — ODM Processing Services

Criterion Precision Machining delivers Medical Precision Machining Parts — ODM Processing Services for medical device teams that need production-ready components, not risky one-offs. From production-intent prototypes to Swiss turned, CNC milled, laser-marked, and fully inspected parts, our ISO-certified team supports surgical instruments, implantable components, orthopedic fasteners, and diagnostic equipment with exacting tolerances and traceable documentation.

Medical precision machined parts

Our Medical Precision Machining Parts Services

Production-ready machining, prototyping, turning, milling, marking, finishing, and inspection for regulated medical device components.

Medical Machining

Tight-tolerance machining for surgical instruments, implantable components, orthopedic fasteners, and diagnostic equipment parts using ISO 13485 quality controls and traceable production documentation.

Production Prototyping

Production-intent prototype runs made on production equipment and inspected with production metrology, helping qualified medical parts move into higher-volume manufacturing with fewer delays.

CNC Milling

Advanced 3-, 4-, and 5-axis milling for complex medical components, tight pockets, fine features, and challenging materials requiring high accuracy and repeatability.

Swiss Turning

High-repeatability Swiss screw machining for small-diameter medical components, micro-features, orthopedic fasteners, surgical pins, and intricate turned parts down to very small diameters.

CNC Turning

Precision CNC turning for cylindrical and complex-geometry medical parts, including live-tooling operations that reduce setups, cycle time, and tolerance stack-up.

Quality Inspection

Certified inspection using CMM, OASIS optical inspection, and Keyence systems, with FAIRs, Certificates of Conformance, and material traceability documentation available.

Technician inspecting precision medical components

Our Production-Ready ODM Process

Engineering Review and Planning

Our team reviews drawings, specifications, materials, tolerances, compliance needs, and production goals. This early technical review helps identify manufacturability risks, inspection requirements, documentation expectations, and the best machining path before work enters the production system.

Production-Intent Prototype Run

Precision Machining and Finishing

Inspection and Documentation

Scalable Production Release

The Criterion Difference

Why Choose Criterion Precision Machining?

Criterion combines advanced equipment, certified systems, and decades of precision manufacturing experience.

Certified Quality

ISO 13485 and ISO 9001 systems support regulated medical device manufacturing requirements.

Advanced Capability

Swiss turning, CNC turning, and 5-axis milling support complex components under one roof.

Tight Tolerances

Tolerances down to ±0.0002 inches help meet demanding performance and fit requirements.

Proven Legacy

Woman-owned, third-generation leadership brings accountability, stability, and long-term manufacturing partnership.

Meet The Criterion Team

Experienced leaders supporting regulated precision machining 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 are medical precision machining parts?

Medical precision machining produces tight-tolerance components for regulated medical applications such as surgical instruments, implantable device components, orthopedic fasteners, and diagnostic equipment parts. At Criterion Precision Machining, work may include Swiss turning, CNC turning, 5-axis milling, laser marking, finishing, and inspection under ISO 13485 and ISO 9001 quality systems.

What does ODM processing include for medical machined parts?

What materials can be used for medical device machining?

How tight are the tolerances for medical precision parts?

Can you support medical prototype to production programs?

What quality documentation is provided with machined parts?

Do you provide UDI laser marking for medical components?

Where does Criterion Precision Machining serve customers?

Still Have Technical Questions?

Share your part requirements with our precision machining team.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485

Medical device quality management certification.

ISO 9001 certification logo

ISO 9001

Certified quality management system standard.

WBENC certification logo

WBENC

Recognized woman-owned business enterprise credential.

Start Your Medical Machining Project

Send your drawings, tolerances, materials, and production goals. Our team will review manufacturability, documentation needs, and next steps for a production-ready machining 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.