Biocompatible Material CNC Machining Services

When patient safety depends on every micron, Criterion Precision Machining delivers CNC machining of biocompatible materials—titanium, PEEK, stainless steel, and more—to tolerances as tight as ± .0002". ISO 13485 certified and FDA registered, we produce implant-ready and surgical-grade components that meet the uncompromising standards of the medical device industry.

CNC machining of biocompatible titanium medical device component in a precision machine shop

Our Biocompatible Material CNC Machining Services

From complex multi-axis milling to Swiss turning, we machine biocompatible materials with the precision medical devices demand.

CNC Milling

Precision 3-, 4-, and 5-axis CNC milling for complex biocompatible material components, including implant housings and surgical instrument parts, with consistent repeatability and tight tolerances.

CNC Turning

High-precision CNC turning for cylindrical and complex geometry biocompatible parts in titanium, stainless steel, and specialty plastics, with tolerances down to ± .0002" and smooth surface finishes.

Swiss Turning

Swiss turning for small-diameter, high-precision biocompatible components with micro-sized features, ideal for minimally invasive device parts, bone screws, and slender surgical instruments.

Prototyping

Production-intent prototyping of biocompatible material components using the same machines and inspection equipment as final production, enabling direct scale-up with no re-qualification required.

Quality Inspection

Certified quality inspection with CMM, OASIS optical systems, and Keyence measuring systems, with no-charge Certificates of Conformance and final inspection reports for every biocompatible part.

Material Expertise

Skilled machining of medical-grade titanium, 316L stainless steel, PEEK, cobalt-chrome, and specialty alloys—materials selected for body compatibility, corrosion resistance, and structural integrity.

Medical-Grade Accuracy

Precision Machined Biocompatible Parts You Can Trust

Medical device manufacturers require more than tight tolerances—they need a machining partner who understands the regulatory, material, and performance demands of biocompatible components. At Criterion, our ISO 13485 and ISO 9001 certifications, FDA registration, and 70+ years of precision machining expertise mean every titanium, PEEK, or stainless steel part we produce is built to perform safely inside or alongside the human body. From prototypes to full production runs, we machine parts right the first time.

Precision CNC machined PEEK and titanium medical components arranged on an inspection surface
The Criterion Difference

Why Choose Criterion Precision Machining?

We combine seven decades of machining heritage with the certifications and capabilities that medical device manufacturers demand.

ISO 13485 Certified

Our ISO 13485 and ISO 9001 certifications ensure every biocompatible component meets stringent medical device quality management requirements.

Tolerances to ± .0002"

We hold tolerances as tight as ± .0002" across titanium, PEEK, and stainless steel—critical for implantable and surgical-grade medical parts.

FDA & ITAR Registered

Criterion is FDA and ITAR registered, qualifying us to machine regulated biocompatible components for U.S. medical device OEMs and defense suppliers.

70+ Years of Legacy

Founded in 1953 and now in its third generation, Criterion brings unmatched precision machining experience to Ohio's medical device supply chain.

Meet The Criterion Team

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

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 an example of a biocompatible material?

Common biocompatible materials used in CNC machining include titanium (Grade 5 and Grade 23), medical-grade stainless steel (316L), PEEK (polyether ether ketone), cobalt-chrome alloys, and certain specialty plastics. These materials are chosen for their non-reactive properties, corrosion resistance, and ability to function safely in or near the human body.

What makes a material medical grade?

What is CNC in medical devices?

What certifications should a CNC machining shop have for medical device work?

Can Criterion machine titanium and PEEK for implantable device components?

What tolerances can Criterion hold on biocompatible material parts?

Does Criterion offer prototyping for medical device components before full production?

What documentation does Criterion provide with biocompatible machined parts?

Still Have Questions About Biocompatible CNC Machining?

Talk to our experts for a free consultation on your medical device component requirements.

Where We Serve

Criterion ships precision-machined biocompatible components to medical device manufacturers across the United States.

Nationwide (U.S.)

Service Area

Brook Park, Ohio

Headquarters

Since 1953

In Business

Do We Service Your Area?

Contact us to confirm we can fulfill your biocompatible machining requirements from your location.

Certified & Trusted

Awards and Recognition

ISO 13485 certification badge for Criterion Precision Machining

ISO 13485 Certified

Medical device quality management system certification.

ISO 9001 certification badge for Criterion Precision Machining

ISO 9001 Certified

International standard for quality management systems.

WBENC Women's Business Enterprise certification badge

WBENC Certified

Women's Business Enterprise National Council certified.

Get a Quote for Biocompatible Material CNC Machining

Submit your part drawings, material specifications, and tolerance requirements. Our team will respond promptly with a detailed quote and project assessment tailored to your medical device 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.