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
Trusted By Industry Leaders

Success Stories

See how leading medical device manufacturers rely on Criterion for mission-critical surgical instrument components.

"Criterion's Swiss turning capabilities transformed our micro-component production. Their ± .0002" tolerances on titanium surgical instruments consistently meet our exacting FDA requirements."

Dr. Patricia Chen

"We struggled finding a partner who understood surgical instrument machining at the complexity level we needed. Criterion solved it with their 5-Axis CNC and proven quality systems."

James Kovacs

"For surgical instrument machining, Criterion delivers precision that competitors simply cannot match. Their woman-owned status and ITAR registration give us confidence in every delivery."

Margaret Thornton

"Tight deadline on surgical forceps prototyping? Criterion turned our design around in days. Their production-intent prototyping ensured zero rework when we scaled to full manufacturing."

Robert Sullivan

"Criterion's Quality Inspection service with PC-DMIS CMM and OASIS optical system eliminated our inspection bottleneck. Zero-charge documentation saved us thousands in compliance overhead."

Linda Vasquez

"Thirty years of partnership with Criterion speaks volumes. Their CNC turning consistently handles our stainless steel scalpel handles with 0.0002" precision and reliability."

Edward Walsh

"Their 5-axis CNC milling capability on our complex implant fixation devices is exceptional. Criterion's ProShop ERP integration and SPC tracking ensure traceability and repeatability every run."

Dr. Howard Steinberg

"As an aerospace supplier, I recognize Criterion's precision machining as industry-leading. Their 'no failure' philosophy and ISO 13485 certification make them essential for mission-critical work."

Victor Nakamura

"Criterion's Swiss turning capabilities transformed our micro-component production. Their ± .0002" tolerances on titanium surgical instruments consistently meet our exacting FDA requirements."

Dr. Patricia Chen

"We struggled finding a partner who understood surgical instrument machining at the complexity level we needed. Criterion solved it with their 5-Axis CNC and proven quality systems."

James Kovacs

"For surgical instrument machining, Criterion delivers precision that competitors simply cannot match. Their woman-owned status and ITAR registration give us confidence in every delivery."

Margaret Thornton

"Tight deadline on surgical forceps prototyping? Criterion turned our design around in days. Their production-intent prototyping ensured zero rework when we scaled to full manufacturing."

Robert Sullivan

"Criterion's Quality Inspection service with PC-DMIS CMM and OASIS optical system eliminated our inspection bottleneck. Zero-charge documentation saved us thousands in compliance overhead."

Linda Vasquez

"Thirty years of partnership with Criterion speaks volumes. Their CNC turning consistently handles our stainless steel scalpel handles with 0.0002" precision and reliability."

Edward Walsh

"Their 5-axis CNC milling capability on our complex implant fixation devices is exceptional. Criterion's ProShop ERP integration and SPC tracking ensure traceability and repeatability every run."

Dr. Howard Steinberg

"As an aerospace supplier, I recognize Criterion's precision machining as industry-leading. Their 'no failure' philosophy and ISO 13485 certification make them essential for mission-critical work."

Victor Nakamura

"Criterion's Swiss turning capabilities transformed our micro-component production. Their ± .0002" tolerances on titanium surgical instruments consistently meet our exacting FDA requirements."

Dr. Patricia Chen

"We struggled finding a partner who understood surgical instrument machining at the complexity level we needed. Criterion solved it with their 5-Axis CNC and proven quality systems."

James Kovacs

"For surgical instrument machining, Criterion delivers precision that competitors simply cannot match. Their woman-owned status and ITAR registration give us confidence in every delivery."

Margaret Thornton

"Tight deadline on surgical forceps prototyping? Criterion turned our design around in days. Their production-intent prototyping ensured zero rework when we scaled to full manufacturing."

Robert Sullivan

"Criterion's Quality Inspection service with PC-DMIS CMM and OASIS optical system eliminated our inspection bottleneck. Zero-charge documentation saved us thousands in compliance overhead."

Linda Vasquez

"Thirty years of partnership with Criterion speaks volumes. Their CNC turning consistently handles our stainless steel scalpel handles with 0.0002" precision and reliability."

Edward Walsh

"Their 5-axis CNC milling capability on our complex implant fixation devices is exceptional. Criterion's ProShop ERP integration and SPC tracking ensure traceability and repeatability every run."

Dr. Howard Steinberg

"As an aerospace supplier, I recognize Criterion's precision machining as industry-leading. Their 'no failure' philosophy and ISO 13485 certification make them essential for mission-critical work."

Victor Nakamura
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.

Tanya DiSalvo, President of Criterion Precision Machining

Tanya DiSalvo

President

As the third-generation owner and President of Criterion Precision Machining, Tanya DiSalvo leads a company with more than 70 years of precision machining heritage. Under her leadership, Criterion has sharpened its focus on the most demanding industries — medical device, aerospace, defense, and photonics — where zero-defect performance is non-negotiable. Tanya has guided strategic investments in advanced multi-axis CNC equipment, quality management systems, and ISO 13485 certification to ensure Criterion remains a trusted partner for surgical instrument manufacturers. Her commitment to people, process, and precision defines the culture at Criterion's Brook Park, Ohio facility. A WBENC-certified women's business enterprise under Tanya's ownership, Criterion continues to grow as a supplier-diversity-qualified precision machining partner for leading medical device OEMs across the United States.

Mike Pinchot, Estimator and Project Manager at Criterion Precision Machining

Mike Pinchot

Estimator/Project Manager

Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, acting as a key point of contact for customers navigating complex surgical instrument machining projects from initial quote through production delivery. With a deep understanding of Criterion's Swiss turning, CNC turning, and multi-axis milling capabilities, Mike translates customer requirements into accurate, competitive estimates while managing project timelines to ensure on-time delivery. His role bridges the customer relationship and the shop floor, coordinating with quality, programming, and production teams to keep mission-critical medical device projects on track. Mike's practical knowledge of tight-tolerance machining and material considerations makes him an invaluable resource for medical device OEMs seeking reliable precision manufacturing partnerships.

David Glass, Chief Financial Officer at Criterion Precision Machining

David Glass

Chief Financial Officer

David Glass serves as Chief Financial Officer at Criterion Precision Machining, overseeing the financial operations and strategic planning that support the company's growth in the medical device, aerospace, and defense sectors. His financial stewardship ensures Criterion maintains the investment capacity to continuously upgrade precision machining equipment, quality systems, and compliance infrastructure required to serve surgical instrument manufacturers. David's work underpins the operational stability that customers depend on when partnering with Criterion for long-term, mission-critical supply agreements. His leadership contributes to Criterion's ability to scale production capacity while maintaining the rigorous cost and quality controls that define the company's reputation across more than seven decades of precision manufacturing.

Kelly Marflak, Quality Manager at Criterion Precision Machining

Kelly Marflak

Quality Manager

Kelly Marflak is the Quality Manager at Criterion Precision Machining, responsible for maintaining and advancing the company's ISO 13485 and ISO 9001 certified quality management system. Kelly oversees multiple precision inspection touchpoints built throughout the manufacturing process, including the Global Advantage CMM with TESTASTAR-sm probe, the OASIS Optical Automatic Smart Inspection System, and Keyence multi-dimension measuring systems. Her role ensures every surgical instrument component leaving Criterion's Brook Park facility meets documented acceptance criteria and is accompanied by the required Certificates of Conformance and inspection reports. Kelly's dedication to process discipline and continuous improvement is central to Criterion's ability to serve medical device customers who operate in zero-tolerance, life-critical environments.

Kellyanne Gottschalk, Internal Systems Manager at Criterion Precision Machining

Kellyanne Gottschalk

Internal Systems Manager

Kellyanne Gottschalk manages Criterion Precision Machining's internal systems, overseeing the ProShop ERP platform and operational workflows that keep the company's precision machining processes running efficiently and transparently. Her role ensures that job routing, documentation, scheduling, and compliance data flow seamlessly between departments — from initial order entry through final inspection and shipment. For medical device customers requiring complete traceability and documentation integrity for surgical instrument components, Kellyanne's work is essential. By maintaining robust ERP-driven processes, she supports Criterion's ability to scale production without sacrificing the quality oversight and regulatory documentation that ISO 13485 certification and FDA registration demand.

Nilda Feliciano, Customer Service at Criterion Precision Machining

Nilda Feliciano

Customer Service

Nilda Feliciano is a key member of Criterion Precision Machining's customer service team, serving as a reliable and responsive point of contact for medical device manufacturers, surgical OEMs, and other mission-critical industry customers. Her role encompasses order coordination, customer communication, and ensuring that clients receive timely updates on their precision machining projects. Nilda's attentiveness to customer needs and her understanding of Criterion's capabilities help facilitate smooth project handoffs, expedite urgent requests, and build the long-term relationships that define Criterion's reputation as a trusted manufacturing partner. Her dedication to exceptional service reflects Criterion's people-powered culture and commitment to going beyond the part.

Bonnie Paletta, Office Administrator at Criterion Precision Machining

Bonnie Paletta

Office Administrator

Bonnie Paletta serves as Office Administrator at Criterion Precision Machining, providing essential organizational support that keeps the business running smoothly day to day. Her responsibilities span administrative coordination, record management, and internal communications — ensuring that Criterion's team can focus on delivering precision surgical instrument components without operational disruption. Bonnie's behind-the-scenes contributions are critical to the efficiency and professionalism that customers experience when working with Criterion. Her long-standing dedication to the company reflects the stable, loyal team culture that has helped Criterion maintain its reputation for reliability and consistency across more than seven decades of precision manufacturing in Brook Park, Ohio.

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