When lives depend on the components you produce, precision isn't negotiable—it's essential. Criterion Precision Machining specializes in manufacturing mission-critical medical device components with tolerances as tight as ±.0002". With ISO 13485 certification and FDA registration, we deliver Swiss turning, CNC milling, and precision inspection services that meet the exacting standards of the medical device industry. From surgical instruments to implantable device components, our advanced manufacturing capabilities ensure every part performs flawlessly.
Comprehensive precision machining solutions for medical device manufacturers who demand absolute accuracy and regulatory compliance.
High-volume production of small-diameter medical components with tight tolerances down to ±.0002". Our multi-axis Swiss turning centers excel at producing slender, intricate parts with exceptional surface finishes for surgical instruments and implantable devices.
Multi-axis precision milling for complex medical components requiring intricate geometries. Our 3-, 4-, and 5-axis capabilities deliver consistent repeatability for critical applications in diagnostic equipment and surgical tools.
High-precision cylindrical and complex geometry medical parts machined to exacting tolerances. Specialized in challenging materials including titanium, stainless steels, and medical-grade plastics for implantable components and instruments.
Production-intent prototyping with the same precision and compliance standards as full production. Test fit, function, and manufacturability before scaling to high-volume production without reprogramming or re-qualification.
Certified quality assurance with Global Advantage CMM, OASIS optical inspection, and Keyence measuring systems. Complete documentation including Certificates of Conformance and inspection reports at no additional charge.
Specialized capabilities for micro-sized features and components with diameters as small as .010". Perfect for miniaturized medical devices requiring deep cuts, fine features, and exceptional precision on challenging materials.
We begin by thoroughly analyzing your specifications, drawings, and tolerances. Our engineering team works with you to select optimal materials—whether titanium, stainless steel, PEEK, or specialty alloys—that meet both your performance requirements and FDA biocompatibility standards. This critical first step ensures manufacturability and regulatory compliance from the start.
Seven decades of precision machining expertise focused exclusively on mission-critical medical applications.
ISO 13485 and ISO 9001 certified with FDA registration, ensuring your components meet all medical device manufacturing standards and regulatory requirements.
Tolerances as tight as ±.0002" with diameters down to .010", backed by advanced CMM inspection and optical measurement systems that verify every dimension.
Extensive experience machining titanium, medical-grade stainless steels, PEEK, and specialty alloys with complete material traceability and biocompatibility documentation.
Since 1953, we've evolved from a general machine shop to a specialized medical component manufacturer, combining generational expertise with cutting-edge Swiss turning and multi-axis CNC technology.
Experienced professionals dedicated to medical device manufacturing excellence.
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.
CNC machining in the medical industry involves using computer-controlled precision equipment — such as CNC mills, lathes, and Swiss turning centers — to manufacture mission-critical components for medical devices, surgical instruments, and implantable parts. Medical CNC machining requires extreme accuracy, biocompatible materials, regulatory compliance, and thorough quality documentation to ensure patient safety. Specialized medical machine shops like Criterion achieve tolerances as tight as ±.0002" to meet the stringent demands of medical device OEMs.
Medical device quality management system compliance
International quality management system standards
FDA registered medical device component manufacturer
Share your specifications and tolerances with us. We'll respond with a detailed quote and technical recommendations within 24-48 hours.
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.