Medical Device Machining Services in North Carolina

North Carolina's medical device sector demands components machined to exacting tolerances—where a single deviation can affect patient outcomes. Criterion Precision Machining delivers ISO 13485-certified Swiss turning, CNC milling, and turning services for surgical instruments, implantable components, and diagnostic equipment, backed by over 70 years of precision manufacturing expertise.

Precision CNC machining of a medical device component in a manufacturing facility

Our Medical Device Machining Services

From prototyping to full production, we deliver precision-machined medical components with the quality and compliance your application demands.

CNC Milling

Precision 3-, 4-, and 5-axis CNC milling for complex, multi-axis medical device components. We hold tight tolerances and deliver consistent repeatability for surgical instruments and diagnostic equipment parts.

CNC Turning

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

Swiss Turning

Multi-axis Swiss turning for small-diameter, high-precision medical components including implantable device parts and micro-features, with diameters as small as .010" and exceptional surface finishes.

Prototyping

Production-intent prototyping for medical devices using the same machines, materials, and quality standards as full production runs—enabling seamless scale-up without reprogramming or re-qualification.

Quality Inspection

ISO 13485-backed inspection services using CMM, OASIS optical systems, and Keyence measuring tools. Certificates of Conformance and final inspection reports are provided at no additional charge.

Material Expertise

Specialized machining of medical-grade materials including titanium, stainless steels, PEEK, specialty plastics, and advanced alloys—matched to the performance requirements of your medical device application.

No-Failure Quality

Precision Machining Built for Medical Device Standards

North Carolina's growing medical device corridor requires a machining partner who understands the stakes. Criterion Precision Machining delivers ISO 13485-certified components—surgical instruments, implantable device parts, and diagnostic equipment components—machined to tolerances as tight as ±.0002". Backed by over 70 years of precision manufacturing heritage and FDA registration, we combine advanced multi-axis equipment with rigorous in-process inspection to ensure every part meets your exact specifications, every time.

Technician inspecting a precision-machined medical device component with CMM equipment
The Criterion Difference

Why Choose Criterion Precision Machining?

We bring decades of certified expertise, advanced technology, and an unwavering commitment to quality to every medical device component we produce.

ISO 13485 Certified

Our ISO 13485 and ISO 9001 certifications ensure every medical component meets rigorous regulatory and quality management standards.

70+ Years of Expertise

Founded in 1953, our three-generation legacy means North Carolina medical device OEMs work with a partner who truly understands mission-critical precision.

Tolerances to ±.0002"

Our advanced Swiss turning and multi-axis CNC equipment routinely holds tolerances down to ±.0002" for the most demanding medical device geometries.

Woman-Owned & FDA Registered

As a WBENC-certified, woman-owned and FDA-registered manufacturer, we meet both supplier diversity and strict medical device compliance requirements.

Meet the Criterion Team

Experienced professionals dedicated to precision, quality, and client success.

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 the difference between NC and CNC machining?

NC (Numerical Control) machining uses pre-programmed punch cards or fixed instructions to control machine movements, while CNC (Computer Numerical Control) machining uses dynamic computer software to control and adjust operations in real time. CNC offers significantly greater precision, flexibility, and repeatability—critical advantages for medical device components requiring tolerances as tight as ±.0002".

Is Criterion Precision Machining ISO 13485 certified for medical device components?

What types of medical device components does Criterion machine?

What tolerances can Criterion hold for medical device machining?

Does Criterion offer prototyping services for medical devices?

What materials does Criterion work with for medical device applications?

Does Criterion provide quality documentation with medical device orders?

Can Criterion machine small, complex medical device components?

Still Have Questions About Medical Device Machining?

Our engineering and quality team is ready to discuss your specific requirements and provide a no-obligation consultation.

Certified & Trusted

Awards and Recognition

ISO 13485 medical device quality management certification logo

ISO 13485 Certified

Medical device quality management system certification, ensuring regulatory compliance.

ISO 9001 quality management certification logo

ISO 9001 Certified

International quality management standard demonstrating consistent, high-quality processes.

WBENC Women's Business Enterprise National Council certification logo

WBENC Certified

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

Get a Quote for Medical Device Machining in North Carolina

Share your component specifications, material requirements, and production volumes. Our team will respond promptly with a detailed, competitive quote backed by over 70 years of precision machining expertise.

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.