Expert Medical Device Contract Manufacturing Services for Class I II III

Precision contract manufacturing for Class I, II, and III medical devices with FDA-compliant processes, ISO 13485 certification, and tolerances down to ±0.0002". From prototyping to full-scale production, we deliver mission-critical components that meet the highest regulatory standards for medical device manufacturers.

Precision medical device components being manufactured on CNC equipment

Our Medical Device Manufacturing Services

Comprehensive precision machining solutions for Class I, II, and III medical device components.

Medical Device Prototyping

Production-intent prototyping for medical devices with same precision and compliance standards as full production, enabling seamless transition to manufacturing.

Swiss Turning

Specialized machining for small-diameter medical components with tolerances down to ±0.0002", ideal for surgical instruments and implantable device parts.

CNC Milling

Multi-axis precision milling for complex medical device geometries, delivering consistent repeatability for critical healthcare applications.

CNC Turning

High-precision turning for cylindrical medical components with tight tolerances, supporting diagnostic equipment and surgical instrument manufacturing.

Quality Inspection

Comprehensive inspection services with CMM technology and automated systems, ensuring full compliance with medical device quality standards.

FDA Compliance

Complete regulatory compliance support including documentation, traceability, and quality systems for Class I, II, and III medical devices.

ISO 13485 Certified

FDA-Compliant Manufacturing Excellence

Partner with a woman-owned precision manufacturer specializing in mission-critical medical device components. Our ISO 13485 certification, FDA registration, and advanced quality systems ensure your Class I, II, and III devices meet the strictest regulatory requirements. From titanium surgical instruments to PEEK implantable components, we deliver the reliability healthcare demands.

ISO 13485 certified manufacturing facility with medical device components
The Criterion Difference

Why Choose Criterion Precision Machining?

Seven decades of precision manufacturing excellence for mission-critical medical applications.

FDA Registered

Full FDA registration and ISO 13485 certification for medical device manufacturing compliance.

Micro-Precision

Tolerances down to ±0.0002" with Swiss turning capabilities for the most demanding components.

Quality Systems

Advanced CMM inspection, automated measurement systems, and comprehensive quality documentation for traceability.

Woman-Owned

WBENC certified woman-owned business providing diverse supplier opportunities for procurement requirements.

Meet Our Leadership Team

Experienced professionals driving medical device manufacturing excellence.

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 classifications does Criterion manufacture components for?

We manufacture precision components for Class I, II, and III medical devices with full FDA registration and ISO 13485 certification ensuring compliance with all regulatory requirements.

What tolerances can you achieve for medical device components?

Do you provide prototyping services for medical devices?

What materials do you work with for medical applications?

How do you ensure quality and compliance for medical device manufacturing?

What is your minimum order quantity for medical device components?

Do you provide certificates of conformance and inspection reports?

What is your typical lead time for medical device components?

Need Medical Device Manufacturing Expertise?

Connect with our team to discuss your precision manufacturing requirements.

Certified & Compliant

Awards and Recognition

ISO 13485 certification badge

ISO 13485

Medical Device Quality Management

ISO 9001 certification badge

ISO 9001

Quality Management System

WBENC certification badge

WBENC Certified

Woman-Owned Business Enterprise

Ready to Discuss Your Medical Device Manufacturing Project?

Get expert guidance on precision manufacturing solutions for your Class I, II, or III medical device components.

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.