Surgical Instrument Machining Services

Surgical instruments demand zero compromise — and Criterion Precision Machining delivers exactly that. From micro-diameter Swiss-turned components to complex multi-axis milled parts, we produce surgical instrument components to tolerances as tight as ± .0002". ISO 13485 certified and FDA registered, we're the precision partner operating where failure is simply not an option.

CNC machinist precision-machining a surgical instrument component in a clean machine shop

Our Surgical Instrument Machining Services

Comprehensive precision machining capabilities purpose-built for surgical instrument components that demand exacting tolerances and absolute reliability.

CNC Milling

Precision 3-, 4-, and 5-axis CNC milling for complex surgical instrument geometries. Delivers consistent repeatability and tight tolerances critical for medical device components.

CNC Turning

High-precision CNC turning for cylindrical and complex surgical instrument parts, achieving tolerances down to ± .0002" with smooth surface finishes on titanium and stainless steel.

Swiss Turning

Specialized Swiss turning for small-diameter, intricate surgical instrument components. Handles diameters as small as .010" with micro-features, deep cuts, and complex geometries.

Prototyping

Production-intent surgical instrument prototypes built on the same machines and to the same compliance standards as final production runs, enabling seamless transition to full-volume manufacturing.

Quality Inspection

Multi-point precision inspection using CMM, OASIS optical systems, and Keyence measurement technology. Certificates of Conformance and final inspection reports provided at no extra charge.

Material Expertise

Expert machining of titanium, stainless steels, PEEK, specialty plastics, and high-performance alloys commonly required for implantable and handheld surgical instrument components.

Zero-Compromise Quality

Precision Machining Built for Surgical-Grade Performance

Surgical instruments operate at the intersection of engineering precision and human outcomes — there is no margin for error. Criterion Precision Machining brings over 70 years of manufacturing expertise, ISO 13485 certification, and advanced multi-axis machining to produce components that meet the strictest FDA and medical device standards. Whether you need slender Swiss-turned tissue-handling parts or complex 5-axis milled instrument bodies, our team delivers documented, repeatable precision that surgical OEMs can depend on.

Close-up of precision-machined stainless steel surgical instrument components laid out on an inspection surface
The Criterion Difference

Why Choose Criterion Precision Machining?

From our Brook Park, Ohio facility, Criterion delivers the certifications, capabilities, and culture that surgical instrument manufacturers demand.

ISO 13485 Certified

Fully ISO 13485 and ISO 9001 certified with FDA and ITAR registration, ensuring every surgical component meets rigorous medical device quality standards.

Tolerances to ± .0002"

Advanced Swiss, CNC turning, and 5-axis milling capabilities achieve sub-half-thousandth tolerances essential for precision surgical instrument parts.

70+ Years of Legacy

Founded in 1953 and now third-generation owned, Criterion brings decades of accumulated expertise serving medical device, aerospace, and defense industries.

Woman-Owned & WBENC Certified

A WBENC-certified women's business enterprise, Criterion supports supplier diversity initiatives while delivering top-tier precision machining for surgical OEMs nationwide.

Meet the Criterion Team

Experienced professionals dedicated to precision, quality, and mission-critical delivery.

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 a CNC in the medical field?

In the medical field, CNC (Computer Numerical Control) refers to automated, computer-controlled machining processes used to manufacture precision components such as surgical instruments, implant parts, and diagnostic equipment components. CNC machining ensures highly consistent, repeatable geometries and tight tolerances — often to ± .0002" — which are essential for components where failure is not an option. Medical CNC machining is typically performed under certified quality management systems such as ISO 13485.

What metal are surgical instruments made of?

Is Criterion Precision Machining ISO 13485 certified?

What tolerances can Criterion achieve for surgical instrument components?

Can Criterion machine titanium and stainless steel for surgical applications?

Does Criterion offer surgical instrument prototyping?

What quality documentation does Criterion provide with surgical instrument orders?

What industries does Criterion Precision Machining serve?

Still Have Questions About Our Capabilities?

Speak directly with our team for a consultation or to request a custom quote for your surgical instrument machining project.

Certified & Trusted

Awards and Recognition

ISO 13485 medical device quality management certification badge

ISO 13485 Certified

Medical device quality management system certification for surgical component manufacturing.

ISO 9001 quality management system certification badge

ISO 9001 Certified

International standard confirming consistent quality management across all machining operations.

WBENC Women's Business Enterprise National Council certification badge

WBENC Certified

Women's Business Enterprise National Council certification recognizing woman-owned business status.

Request a Surgical Instrument Machining Quote

Share your project requirements and one of our precision machining specialists will respond promptly with a tailored quote, capability overview, or consultation — no obligation required.

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.