Medical Device Machining Services in Virginia

Virginia's medical device manufacturers demand components machined to exacting standards—where even the smallest deviation can have serious consequences. Criterion Precision Machining delivers ISO 13485-certified precision machining for surgical instruments, implantable components, and diagnostic equipment, with tolerances down to ±.0002" and a zero-failure commitment built into every part we produce.

Precision medical device components being machined on a CNC machine

Our Medical Device Machining Services

Comprehensive precision machining solutions for medical device components—engineered for compliance, accuracy, and zero-failure performance.

CNC Milling

Multi-axis CNC milling for complex medical device components requiring tight tolerances and consistent repeatability. We offer 3-, 4-, and 5-axis milling to produce intricate geometries in titanium, stainless steel, and specialty plastics.

CNC Turning

High-precision CNC turning for cylindrical and complex medical components with tolerances down to ±.0002". Ideal for surgical instrument parts and implantable device components where surface finish and dimensional accuracy are critical.

Swiss Turning

Specialized Swiss turning for small-diameter, high-precision medical components including micro-sized features down to .010" diameter. Perfect for intricate implantable components and minimally invasive surgical device parts.

Medical Prototyping

Production-intent prototyping for surgical instruments, implantable device components, and diagnostic equipment parts—produced to the same compliance standards as full production runs, enabling a seamless transition to high-volume manufacturing.

Quality Inspection

ISO 13485-certified quality inspection including CMM measurement, OASIS optical inspection, and Keyence systems capable of measuring 99 dimensions on 100 parts simultaneously. Certificates of Conformance and final inspection reports included at no charge.

Materials Expertise

Skilled machining of medical-grade materials including titanium, stainless steels, PEEK, specialty plastics, and advanced alloys—materials chosen for biocompatibility, strength, and compliance with FDA and regulatory standards.

Quality inspector measuring a precision medical component with CMM equipment

Our 5-Step Medical Device Machining Process

Requirements Review & Quoting

We begin by thoroughly reviewing your engineering drawings, material specifications, and regulatory requirements. Our estimators assess tolerances, geometries, and compliance needs—including FDA and ITAR considerations—to provide an accurate, transparent quote tailored to Virginia medical device OEM standards.

Production-Intent Prototyping

Precision CNC Machining

Multi-Point Quality Inspection

Documentation & Delivery

The Criterion Difference

Why Choose Criterion Precision Machining?

For Virginia medical device manufacturers, choosing the right machining partner is a critical decision. Here's what sets Criterion apart.

ISO 13485 Certified

Our ISO 13485 and ISO 9001 certifications mean your medical components are produced within a rigorous quality management system built for regulatory compliance.

Zero-Failure Commitment

We specialize exclusively in 'No Failure' industries—every process, inspection checkpoint, and material selection is designed to eliminate risk for Virginia device manufacturers.

Advanced Capabilities

From Swiss turning of micro-sized components to 5-axis CNC milling, our equipment handles the complex geometries and tight tolerances ±.0002" that medical devices demand.

70+ Years of Precision

Founded in 1953 and now in its third generation of ownership, Criterion brings decades of trusted experience serving medical device OEMs across the United States.

Meet the Criterion Team

Experienced professionals dedicated to precision, quality, and your project's 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 ISO 13485 and ISO 13485 2016?

ISO 13485:2016 is the most current version of the standard, replacing earlier editions. The 2016 revision introduced stronger risk management requirements throughout the product lifecycle, greater emphasis on regulatory compliance across the supply chain, and more rigorous controls for software validation and sterile device manufacturing. Criterion Precision Machining is certified to ISO 13485 (current 2016 version), meaning our quality management system meets the latest requirements for medical device component suppliers.

What are the key principles of ISO 13485?

What materials does Criterion machine for medical device components?

What tolerances can Criterion hold for medical device parts?

Is Criterion FDA registered and ITAR compliant?

Does Criterion provide quality documentation with medical device orders?

Can Criterion handle both prototypes and high-volume production for medical devices?

Does Criterion serve medical device manufacturers in Virginia?

Still Have Questions About Medical Device Machining?

Our precision machining experts are ready to discuss your specific requirements and regulatory needs.

Serving Medical Device Manufacturers Nationwide

Criterion delivers precision medical device components to manufacturers across the United States, from Virginia to the West Coast.

Nationwide USA

Service Coverage

1953

In Business Since

±.0002"

Tolerance Capability

Do We Service Your Area?

Contact us to confirm service availability and get a quote for your Virginia medical device project.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485 Certified

Medical device quality management system certified to the highest international standard.

ISO 9001 certification logo

ISO 9001 Certified

Quality management system certified to the globally recognized ISO 9001 standard.

WBENC Women's Business Enterprise certification logo

WBENC Certified

Women's Business Enterprise National Council certified women-owned business.

Get a Quote for Medical Device Machining in Virginia

Tell us about your component requirements, material specifications, and tolerances. Our team will review your drawings and respond with a detailed quote—backed by ISO 13485 certification and 70+ years of precision machining experience.

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.