CNC Milling
Precision 3-, 4-, and 5-axis CNC milling for complex medical device components. We achieve consistent repeatability and tight tolerances on intricate multi-axis geometries required by surgical and diagnostic applications.
When patient outcomes depend on precision, there is no margin for error. Criterion Precision Machining is ISO 13485 certified and has been delivering mission-critical medical device components since 1953. From surgical instruments to implantable device parts, we machine to tolerances as tight as ± .0002"—with full traceability, rigorous inspection, and zero compromise on quality.
From complex micro-parts to production runs, we deliver ISO 13485 compliant precision machining across every critical medical application.
Precision 3-, 4-, and 5-axis CNC milling for complex medical device components. We achieve consistent repeatability and tight tolerances on intricate multi-axis geometries required by surgical and diagnostic applications.
High-precision CNC turning for cylindrical and complex medical device parts. We hold tolerances down to ± .0002" with smooth surface finishes, handling titanium, stainless steels, and specialty plastics.
Specialized Swiss turning for small-diameter, high-precision medical components. Ideal for surgical instruments and implantable parts requiring diameters as small as .010" and complex micro-features.
Production-intent prototyping for medical devices using the same machines, standards, and inspection equipment as full production orders—enabling a seamless transition to higher-volume manufacturing.
Comprehensive in-process and final inspection using CMM, OASIS optical systems, and Keyence measurement tools. Certificates of Conformance and full inspection reports provided at no charge.
Skilled machining of titanium, stainless steels, PEEK, specialty plastics, and high-performance alloys—materials commonly specified for implantable and surgical medical device applications.
Medical device manufacturing demands more than precision—it demands a documented, auditable quality management system at every step. Criterion is ISO 13485 and ISO 9001 certified, FDA and ITAR registered, and has been trusted by leading medical device OEMs for decades. Our integrated QMS, advanced inspection technology, and experienced team ensure every component—from surgical instrument parts to implantable device elements—meets your design intent, regulatory requirements, and zero-defect expectations.
We combine seven decades of machining heritage with cutting-edge technology and a certified quality system built specifically for medical device compliance.
Our ISO 13485 and ISO 9001 certifications, plus FDA and ITAR registration, mean your medical device components are produced under a rigorously audited quality management system.
We consistently hold tolerances as tight as ± .0002", meeting the exacting specifications required for surgical instruments, implantables, and diagnostic device components.
Our Global Advantage CMM, OASIS optical inspection system, and Keyence measurement tools provide comprehensive, multi-point quality verification with full documentation at no extra charge.
Founded in 1953 and now in its third generation of ownership, Criterion has a proven legacy of serving 'No Failure' industries, including medical device, aerospace, defense, and photonics.
Experienced professionals dedicated to precision, quality, and mission-critical results.
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.
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.
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.
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.
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.
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.
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.
The most relevant ISO standard for medical device machining is ISO 13485, which specifies requirements for a quality management system (QMS) where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. ISO 9001 is a general-purpose QMS standard also widely applied in precision machining. Criterion holds both ISO 13485 and ISO 9001 certifications.
Speak directly with our team for expert guidance and a no-obligation project consultation.
Certified quality management system for medical device manufacturing.
Internationally recognized standard for quality management systems.
Nationally certified Women's Business Enterprise.
Share your part specifications, drawings, or project requirements and our team will respond with a detailed quote. All inquiries are handled with strict confidentiality.
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.
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.