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.

Service Process

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

Trusted by Industry Leaders

Success Stories

See how Virginia and nationwide medical device manufacturers rely on Criterion for zero-failure precision components.

"Criterion's Swiss turning capabilities are exceptional. We needed micro-precision components for our surgical instruments, and their ±.0002" tolerances exceeded our specifications. Reliable partner."

Dr. Rebecca Chen

"We struggled with consistent quality on complex geometries until we partnered with Criterion. Their ProShop ERP and CMM inspection system eliminated our defect rate completely. Game-changer."

James Hartley

"For medical device machining virginia, Criterion stands out with ISO 13485 certification and FDA registration. Their expertise in critical components gives us competitive confidence in this region."

Sarah Mitchell

"We needed prototype runs delivered in two weeks for a critical diagnostic device. Criterion's rapid turnaround on production-intent prototyping, without re-programming for full production, saved us months."

Marcus Thompson

"Criterion's CNC milling and 5-axis capabilities handle our most demanding aerospace components with precision. Their quality documentation and inspection reports are thorough and no-charge. Exceptional value."

Thomas Westbrook

"Working with Criterion for eight years. Their team listens, understands our tolerance requirements, and delivers consistently. Woman-owned and WBENC-certified—proud to support them."

Patricia Gonzalez

"Their Global Advantage CMM with PC-DMIS and OASIS optical inspection system measures 99 dimensions simultaneously. Precision and speed in quality inspection set them apart from competitors."

David Kowalski

"Medical device machining virginia requires partners who understand FDA and ITAR compliance. Criterion's 70-year legacy, ISO 13485 certification, and defense clearance position them as industry leaders."

Amanda Foster

"Criterion's Swiss turning capabilities are exceptional. We needed micro-precision components for our surgical instruments, and their ±.0002" tolerances exceeded our specifications. Reliable partner."

Dr. Rebecca Chen

"We struggled with consistent quality on complex geometries until we partnered with Criterion. Their ProShop ERP and CMM inspection system eliminated our defect rate completely. Game-changer."

James Hartley

"For medical device machining virginia, Criterion stands out with ISO 13485 certification and FDA registration. Their expertise in critical components gives us competitive confidence in this region."

Sarah Mitchell

"We needed prototype runs delivered in two weeks for a critical diagnostic device. Criterion's rapid turnaround on production-intent prototyping, without re-programming for full production, saved us months."

Marcus Thompson

"Criterion's CNC milling and 5-axis capabilities handle our most demanding aerospace components with precision. Their quality documentation and inspection reports are thorough and no-charge. Exceptional value."

Thomas Westbrook

"Working with Criterion for eight years. Their team listens, understands our tolerance requirements, and delivers consistently. Woman-owned and WBENC-certified—proud to support them."

Patricia Gonzalez

"Their Global Advantage CMM with PC-DMIS and OASIS optical inspection system measures 99 dimensions simultaneously. Precision and speed in quality inspection set them apart from competitors."

David Kowalski

"Medical device machining virginia requires partners who understand FDA and ITAR compliance. Criterion's 70-year legacy, ISO 13485 certification, and defense clearance position them as industry leaders."

Amanda Foster

"Criterion's Swiss turning capabilities are exceptional. We needed micro-precision components for our surgical instruments, and their ±.0002" tolerances exceeded our specifications. Reliable partner."

Dr. Rebecca Chen

"We struggled with consistent quality on complex geometries until we partnered with Criterion. Their ProShop ERP and CMM inspection system eliminated our defect rate completely. Game-changer."

James Hartley

"For medical device machining virginia, Criterion stands out with ISO 13485 certification and FDA registration. Their expertise in critical components gives us competitive confidence in this region."

Sarah Mitchell

"We needed prototype runs delivered in two weeks for a critical diagnostic device. Criterion's rapid turnaround on production-intent prototyping, without re-programming for full production, saved us months."

Marcus Thompson

"Criterion's CNC milling and 5-axis capabilities handle our most demanding aerospace components with precision. Their quality documentation and inspection reports are thorough and no-charge. Exceptional value."

Thomas Westbrook

"Working with Criterion for eight years. Their team listens, understands our tolerance requirements, and delivers consistently. Woman-owned and WBENC-certified—proud to support them."

Patricia Gonzalez

"Their Global Advantage CMM with PC-DMIS and OASIS optical inspection system measures 99 dimensions simultaneously. Precision and speed in quality inspection set them apart from competitors."

David Kowalski

"Medical device machining virginia requires partners who understand FDA and ITAR compliance. Criterion's 70-year legacy, ISO 13485 certification, and defense clearance position them as industry leaders."

Amanda Foster
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.

Tanya DiSalvo, President of Criterion Precision Machining

Tanya DiSalvo

President

Tanya DiSalvo leads Criterion Precision Machining as its third-generation owner, continuing a legacy of precision excellence that dates back to 1953. Under her leadership, Criterion has sharpened its focus on mission-critical industries—medical device, aerospace, defense, and photonics—while investing in advanced machining technology and certified quality systems. As a Women's Business Enterprise National Council (WBENC)-certified company, Criterion reflects Tanya's commitment to building a people-powered organization capable of delivering components where failure is simply not an option. Her vision has driven the company's ISO 13485 and ISO 9001 certifications, FDA and ITAR registrations, and its reputation as a trusted partner for medical device manufacturers across Virginia and the United States.

Mike Pinchot, Estimator and Project Manager at Criterion Precision Machining

Mike Pinchot

Estimator/Project Manager

Mike Pinchot serves as Criterion's Estimator and Project Manager, acting as the critical bridge between customer requirements and shop floor execution. With deep knowledge of precision machining capabilities—including Swiss turning, CNC turning, and 5-axis milling—Mike translates complex medical device drawings and tight-tolerance specifications into accurate, competitive quotes and reliable production timelines. His project management expertise ensures that each job, from prototype through full production, is tracked, communicated, and delivered to meet the demanding schedules of medical device OEMs. Mike's attention to detail and customer-focused approach make him a trusted point of contact for Virginia clients and nationwide partners alike.

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 keep the company positioned for long-term growth. His financial stewardship supports Criterion's continued investment in advanced machining equipment, quality inspection systems, and compliance infrastructure—all essential to maintaining the high standards required by medical device and aerospace customers. David's work ensures that Criterion remains a financially stable, reliable partner for Virginia medical device manufacturers and mission-critical industries that depend on consistent, on-time delivery of precision components.

Kelly Marflak, Quality Manager at Criterion Precision Machining

Kelly Marflak

Quality Manager

Kelly Marflak leads Criterion's certified Quality Assurance program as Quality Manager, ensuring every medical device component meets the exacting standards required by ISO 13485, ISO 9001, and FDA regulations. Kelly oversees the company's multi-point inspection process, managing systems including the Global Advantage CMM with PC-DMIS software, the OASIS Optical Automatic Smart Inspection System, and Keyence measuring systems. Her rigorous approach to quality documentation—including Certificates of Conformance and final inspection reports—gives medical device manufacturers in Virginia and beyond the confidence that every part shipped is fully compliant, traceable, and ready for regulatory review.

Kellyanne Gottschalk, Internal Systems Manager at Criterion Precision Machining

Kellyanne Gottschalk

Internal Systems Manager

Kellyanne Gottschalk manages Criterion's internal systems as Internal Systems Manager, ensuring the operational infrastructure that supports precision machining and quality compliance runs smoothly. She oversees the ProShop ERP system that connects quoting, scheduling, production, and quality data across the organization. Kellyanne's work is integral to Criterion's ability to maintain traceability, meet regulatory documentation requirements, and deliver consistent results for medical device customers who require full production records. Her systems management ensures that Criterion's processes are as reliable and precise as the components the company produces.

Nilda Feliciano, Customer Service representative at Criterion Precision Machining

Nilda Feliciano

Customer Service

Nilda Feliciano is a key member of Criterion's customer-facing team, providing responsive and knowledgeable customer service to medical device manufacturers and other mission-critical clients. Nilda serves as an essential communication link between customers and Criterion's production and project management teams, ensuring that inquiries, order updates, and delivery schedules are handled with clarity and professionalism. For Virginia-based medical device companies sourcing precision components, Nilda's attentive service style helps build the long-term relationships that are central to Criterion's reputation as a trusted machining partner.

Bonnie Paletta, Office Administrator at Criterion Precision Machining

Bonnie Paletta

Office Administrator

Bonnie Paletta keeps Criterion's day-to-day operations running efficiently as Office Administrator. Her organizational expertise supports the administrative functions that underpin Criterion's ability to deliver precision components reliably and on schedule. From coordinating documentation and correspondence to supporting the leadership team's operational needs, Bonnie plays an important behind-the-scenes role in maintaining the professional, structured environment that medical device and aerospace clients expect from a certified precision machining partner. Her dedication to detail reflects the same standard of excellence that defines every part Criterion produces.

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