Medical Machining Specialists with ISO Certified Quality

Criterion Precision Machining delivers mission-critical medical components with exacting tolerances down to ±0.0002". Our ISO 13485 certified facility combines 70+ years of expertise with advanced Swiss turning, 5-axis milling, and quality assurance programs to ensure zero-failure performance for medical device manufacturers.

Precision medical device components being machined on CNC equipment

Our Medical Machining Services

Comprehensive precision machining solutions for mission-critical medical device components.

Swiss Turning

Ultra-precise Swiss turning for small-diameter medical components with tolerances down to ±0.0002" and exceptional surface finishes.

CNC Milling

Advanced 3-, 4-, and 5-axis milling for complex medical geometries requiring tight tolerances and consistent repeatability.

CNC Turning

High-precision turning for cylindrical medical components with complex geometries and smooth surface finishes in challenging materials.

Medical Prototyping

Production-intent prototyping for surgical instruments, implantable devices, and diagnostic equipment with full compliance testing.

Quality Inspection

Certified quality assurance with CMM inspection, dimensional analysis, and complete documentation including Certificates of Conformance.

Material Expertise

Specialized machining of medical-grade titanium, stainless steels, PEEK, and other biocompatible materials for critical applications.

ISO 13485 Certified

Precision Medical Machining That Never Fails

When medical device manufacturers need components that perform flawlessly, they trust Criterion's 70+ years of precision machining expertise. Our ISO 13485 certified facility delivers surgical instruments, implantable device components, and diagnostic equipment parts with tolerances down to ±0.0002". Every component undergoes rigorous quality inspection using advanced CMM technology and comprehensive documentation to ensure regulatory compliance and patient safety.

Medical device components with precision measurement tools and quality documentation
The Criterion Difference

Why Choose Criterion Precision Machining?

Decades of expertise delivering mission-critical medical components with zero-failure performance.

ISO Certified

ISO 13485 and ISO 9001 certified quality management systems for medical device manufacturing.

Micro Precision

Tolerances down to ±0.0002" with advanced Swiss turning and multi-axis machining capabilities.

Medical Expertise

Specialized in biocompatible materials and FDA-regulated medical device component manufacturing.

Quality Assurance

Advanced CMM inspection with complete documentation and Certificates of Conformance included at no charge.

Meet Our Medical Machining Team

Expert professionals dedicated to precision and quality.

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 certifications does Criterion hold?

Criterion is ISO 13485 certified for medical device quality management systems and ISO 9001 certified for general quality management. We are also FDA registered and maintain strict compliance with medical device manufacturing regulations.

What tolerances can you achieve for medical components?

Do you provide documentation for medical device components?

What materials do you machine for medical applications?

Can you handle prototype development for medical devices?

What is your typical lead time for medical components?

Do you offer secondary operations for medical components?

What industries do you serve besides medical devices?

Need Medical Machining Expertise?

Speak with our medical device specialists about your precision machining requirements.

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 system certification

WBENC membership certification logo

WBENC Member

Women's Business Enterprise certified

Ready to Discuss Your Medical Machining Project?

Contact our medical device specialists for a detailed quote and project consultation.

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.