CNC Milling
Precision 3-, 4-, and 5-axis CNC milling for complex, multi-axis medical device components. We hold tight tolerances and deliver consistent repeatability for surgical instruments and diagnostic equipment parts.
North Carolina's medical device sector demands components machined to exacting tolerances—where a single deviation can affect patient outcomes. Criterion Precision Machining delivers ISO 13485-certified Swiss turning, CNC milling, and turning services for surgical instruments, implantable components, and diagnostic equipment, backed by over 70 years of precision manufacturing expertise.
From prototyping to full production, we deliver precision-machined medical components with the quality and compliance your application demands.
Precision 3-, 4-, and 5-axis CNC milling for complex, multi-axis medical device components. We hold tight tolerances and deliver consistent repeatability for surgical instruments and diagnostic equipment parts.
High-precision CNC turning for cylindrical and complex geometry medical parts, achieving tolerances down to ±.0002" with smooth surface finishes in titanium, stainless steel, and specialty alloys.
Multi-axis Swiss turning for small-diameter, high-precision medical components including implantable device parts and micro-features, with diameters as small as .010" and exceptional surface finishes.
Production-intent prototyping for medical devices using the same machines, materials, and quality standards as full production runs—enabling seamless scale-up without reprogramming or re-qualification.
ISO 13485-backed inspection services using CMM, OASIS optical systems, and Keyence measuring tools. Certificates of Conformance and final inspection reports are provided at no additional charge.
Specialized machining of medical-grade materials including titanium, stainless steels, PEEK, specialty plastics, and advanced alloys—matched to the performance requirements of your medical device application.
North Carolina's growing medical device corridor requires a machining partner who understands the stakes. Criterion Precision Machining delivers ISO 13485-certified components—surgical instruments, implantable device parts, and diagnostic equipment components—machined to tolerances as tight as ±.0002". Backed by over 70 years of precision manufacturing heritage and FDA registration, we combine advanced multi-axis equipment with rigorous in-process inspection to ensure every part meets your exact specifications, every time.
See how we've helped leading medical device manufacturers achieve mission-critical precision and compliance.
We bring decades of certified expertise, advanced technology, and an unwavering commitment to quality to every medical device component we produce.
Our ISO 13485 and ISO 9001 certifications ensure every medical component meets rigorous regulatory and quality management standards.
Founded in 1953, our three-generation legacy means North Carolina medical device OEMs work with a partner who truly understands mission-critical precision.
Our advanced Swiss turning and multi-axis CNC equipment routinely holds tolerances down to ±.0002" for the most demanding medical device geometries.
As a WBENC-certified, woman-owned and FDA-registered manufacturer, we meet both supplier diversity and strict medical device compliance requirements.
Experienced professionals dedicated to precision, quality, and client success.
President
As the third-generation owner of Criterion Precision Machining, Tanya DiSalvo leads the company with a commitment to the precision and quality standards that have defined Criterion since 1953. Under her leadership, Criterion has grown into a nationally recognized, WBENC-certified woman-owned precision machining company serving the medical device, aerospace, defense, and photonics industries. Tanya champions continuous investment in advanced machining technology and quality management systems, ensuring that clients across North Carolina and the broader United States receive components that meet the most demanding specifications in mission-critical applications.
Estimator/Project Manager
Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, acting as a key point of contact for clients from initial quote through final delivery. With deep knowledge of precision machining processes—including Swiss turning, CNC turning, and multi-axis milling—Mike ensures that each project is accurately scoped, priced, and executed to meet the tight tolerances and quality standards required by medical device manufacturers. His hands-on approach and technical expertise help streamline the path from design intent to production-ready components, making him an invaluable resource for North Carolina OEMs seeking reliable machining partnerships.
Chief Financial Officer
David Glass serves as Chief Financial Officer at Criterion Precision Machining, overseeing the financial operations that enable Criterion's continued investment in advanced precision equipment and quality systems. His strategic financial stewardship supports the company's long-term growth and its ability to deliver consistent value to clients in the medical device, aerospace, and defense industries. David's role is integral to maintaining the operational stability and supplier reliability that medical device OEMs in North Carolina and across the United States depend on when sourcing mission-critical components.
Quality Manager
Kelly Marflak is the Quality Manager at Criterion Precision Machining, responsible for maintaining and advancing the company's ISO 13485 and ISO 9001-certified quality management systems. She oversees all inspection processes—including CMM, OASIS optical inspection, and Keyence measurement systems—ensuring that every component shipped to medical device clients meets or exceeds specification. Kelly's rigorous approach to quality assurance is central to Criterion's reputation as a no-failure supplier, providing medical device manufacturers in North Carolina and beyond with the documented traceability and compliance records required in regulated industries.
Internal Systems Manager
Kellyanne Gottschalk manages Criterion's internal systems, including the ProShop ERP platform that coordinates scheduling, quality records, and production workflows across the facility. Her work ensures that every order—from a prototype run to a high-volume production batch—is tracked with full transparency and executed efficiently. By maintaining robust internal processes, Kellyanne helps Criterion deliver on its commitment to on-time, high-quality precision components for medical device clients in North Carolina and throughout the United States.
Customer Service
Nilda Feliciano is a cornerstone of Criterion's customer service team, serving as a primary liaison between clients and the production floor. She ensures that medical device OEMs and procurement teams receive timely updates, clear communication, and prompt resolution of any questions related to their orders. Nilda's dedication to responsive, personalized service reflects Criterion's broader commitment to building long-term partnerships with clients who rely on mission-critical precision machined components.
Office Administrator
Bonnie Paletta keeps Criterion's daily operations running smoothly as Office Administrator, coordinating administrative functions that support the entire team. Her organizational expertise and attention to detail ensure that documentation, correspondence, and office processes align with the high standards Criterion upholds across all departments. Bonnie's behind-the-scenes contributions are essential to the responsive, professional experience that medical device clients have come to expect from Criterion Precision Machining.
What is the difference between NC and CNC machining?
NC (Numerical Control) machining uses pre-programmed punch cards or fixed instructions to control machine movements, while CNC (Computer Numerical Control) machining uses dynamic computer software to control and adjust operations in real time. CNC offers significantly greater precision, flexibility, and repeatability—critical advantages for medical device components requiring tolerances as tight as ±.0002".
Is Criterion Precision Machining ISO 13485 certified for medical device components?
What types of medical device components does Criterion machine?
What tolerances can Criterion hold for medical device machining?
Does Criterion offer prototyping services for medical devices?
What materials does Criterion work with for medical device applications?
Does Criterion provide quality documentation with medical device orders?
Can Criterion machine small, complex medical device components?
Our engineering and quality team is ready to discuss your specific requirements and provide a no-obligation consultation.
Medical device quality management system certification, ensuring regulatory compliance.
International quality management standard demonstrating consistent, high-quality processes.
Women's Business Enterprise National Council certification, recognizing woman-owned business status.
Share your component specifications, material requirements, and production volumes. Our team will respond promptly with a detailed, competitive quote backed by over 70 years of precision machining expertise.
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