Expert Medical Precision Fabrication Services for Device Manufacturers

Partner with Criterion Precision Machining for mission-critical medical device components that meet FDA standards and ISO 13485 requirements. Our advanced Swiss turning, CNC milling, and quality inspection capabilities deliver the exacting tolerances and consistent reliability your medical devices demand, ensuring patient safety and regulatory compliance.

Precision medical device components being manufactured on advanced CNC machinery

Our Medical Precision Fabrication Services

Complete manufacturing solutions for medical device components with FDA compliance and ISO 13485 certification.

Swiss Turning

Complex medical components with tight tolerances down to ±0.0002 inches for small-diameter, high-volume production of surgical instruments and implantable device parts.

CNC Milling

Precision 3-, 4-, and 5-axis milling for intricate medical device housings, brackets, and complex multi-axis components requiring exceptional accuracy.

CNC Turning

High-precision cylindrical medical components including pins, rods, and complex geometry parts for surgical and diagnostic equipment applications.

Prototyping

Production-intent prototyping for medical devices, testing fit, function, and manufacturability before full-scale production with same quality standards.

Quality Inspection

Comprehensive quality assurance with CMM inspection, optical measurement systems, and complete documentation including Certificates of Conformance.

ISO 13485 Certified

FDA-Compliant Medical Device Manufacturing Excellence

Criterion Precision Machining delivers mission-critical medical device components with exacting tolerances where failure is not an option. Our FDA-registered facility combines advanced Swiss turning and multi-axis CNC capabilities with rigorous quality systems to ensure your surgical instruments, implantable devices, and diagnostic equipment meet the highest medical industry standards and regulatory requirements.

Medical device components on inspection table with precision measurement equipment
The Criterion Difference

Why Choose Criterion Precision Machining?

Over 70 years of precision manufacturing excellence serving mission-critical medical device applications.

Medical Compliance

FDA registered facility with ISO 13485 and ISO 9001 certifications ensuring regulatory compliance.

Extreme Precision

Tight tolerances down to ±0.0002 inches with advanced CMM inspection and quality documentation.

Advanced Technology

Swiss turning, 5-axis CNC milling, and optical inspection systems for complex medical components.

Trusted Partner

Woman-owned business with 70+ years serving medical device manufacturers like Smith & Nephew.

Meet The Criterion Team

Expert leadership driving medical manufacturing excellence since 1953.

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 medical device components can Criterion manufacture?

We specialize in surgical instruments, implantable device components, diagnostic equipment parts, and other precision medical components requiring tight tolerances and FDA compliance.

Do you have medical industry certifications?

What tolerances can you achieve for medical components?

Can you handle medical device prototyping?

What materials do you work with for medical devices?

Do you provide quality documentation?

What is your experience with medical device manufacturers?

Can you handle both small and large volume medical device orders?

Ready to Discuss Your Medical Device Project?

Connect with our medical manufacturing experts for a detailed consultation and quote.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485 Certified

Medical device quality management certification

ISO 9001 certification logo

ISO 9001 Certified

Quality management systems certification

FDA registered facility badge

FDA Registered

Registered medical device manufacturing facility

Start Your Medical Device Manufacturing Project

Get expert guidance and a detailed quote for your precision medical component needs.

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.