ISO 13485 Certified Catheter Manufacturers

Criterion Precision Machining supports catheter and medical device programs with ISO 13485 certified precision machining, traceable quality systems, and tight-tolerance component production. From production-intent prototypes to Swiss-turned micro-parts, laser marking, and inspection documentation, our team helps OEMs reduce supplier risk and move regulated components toward repeatable, validated manufacturing.

ISO 13485 catheter component manufacturing

Our Catheter Manufacturing Services

Certified precision machining, marking, finishing, and inspection for catheter and medical device component programs.

Medical Machining

ISO 13485 certified machining for surgical instruments, implantable device components, orthopedic fasteners, diagnostic equipment parts, and other regulated medical device components requiring traceability and repeatable quality.

Swiss Turning

Small-diameter Swiss screw machining for high-repeatability catheter-related components, micro-features, surgical pins, fasteners, and intricate parts with diameters as small as .010 inches.

CNC Turning

Precision CNC turning for cylindrical and complex-geometry medical components, with live tooling options that reduce setups, tolerance stack-up, handling, and production variability.

CNC Milling

Advanced 3-, 4-, and 5-axis milling for complex medical device components, tight pockets, fine features, and production runs requiring close-tolerance repeatability.

Laser Marking

In-house fiber laser marking for UDI, serialization, lot numbers, 2D matrix codes, logos, and permanent identification on regulated medical device components.

Quality Inspection

Certified inspection using CMM, OASIS optical systems, and Keyence image measurement, with FAIRs, Certificates of Conformance, and material traceability documentation available.

Precision inspection of catheter component

Our Certified Manufacturing Process

Review Drawings And Requirements

Our team reviews drawings, materials, tolerance requirements, documentation needs, and regulatory expectations. This early manufacturability review helps identify machining risks, inspection strategy, and opportunities to consolidate secondary operations under one certified quality system.

Build Production-Intent Prototypes

Machine Critical Components

Finish And Mark Parts

Inspect And Document

The Criterion Difference

Why Choose Criterion Precision Machining?

Criterion Precision Machining helps medical device OEMs source complex components with confidence.

Certified

ISO 13485 certification supports controlled processes for regulated catheter and medical device component programs.

Precise

Machining capabilities support tolerances down to ±0.0002 inches for mission-critical micro-components.

Verified

CMM, optical, and Keyence inspection systems help verify complex features before shipment.

Accountable

In-house finishing, marking, EDM, and documentation reduce outside-vendor risk for regulated parts.

Meet The Criterion Team

Experienced leaders supporting regulated precision manufacturing programs.

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 does ISO 13485 mean for catheter manufacturing?

ISO 13485 is a quality management standard specific to medical devices. For catheter-related components, it supports controlled processes, documented procedures, traceability, inspection discipline, and risk-based quality practices. Criterion Precision Machining is ISO 13485 certified, helping OEMs source precision machined parts from a supplier aligned with regulated medical device manufacturing expectations.

Do you manufacture complete catheters or catheter components?

What materials can be used for catheter-related components?

How tight are your machining tolerances?

Can you support catheter component prototyping?

What inspection documentation is available?

Do you provide UDI laser marking for medical devices?

Where does Criterion Precision Machining serve customers?

Need Help With Requirements?

Talk with our experts about specifications, tolerances, and documentation.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485

Medical device quality management certification.

ISO 9001 certification logo

ISO 9001

Certified quality management system standard.

WBENC certification logo

WBENC

Recognized woman-owned business certification.

Start Your Catheter Component Program

Share your catheter component drawings, specifications, materials, quantities, and quality requirements. Our team will review manufacturability, inspection needs, and documentation expectations for your regulated program.

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.