CNC Milling
Precision 3-, 4-, and 5-axis CNC milling for complex biocompatible material components, including implant housings and surgical instrument parts, with consistent repeatability and tight tolerances.
When patient safety depends on every micron, Criterion Precision Machining delivers CNC machining of biocompatible materials—titanium, PEEK, stainless steel, and more—to tolerances as tight as ± .0002". ISO 13485 certified and FDA registered, we produce implant-ready and surgical-grade components that meet the uncompromising standards of the medical device industry.
From complex multi-axis milling to Swiss turning, we machine biocompatible materials with the precision medical devices demand.
Precision 3-, 4-, and 5-axis CNC milling for complex biocompatible material components, including implant housings and surgical instrument parts, with consistent repeatability and tight tolerances.
High-precision CNC turning for cylindrical and complex geometry biocompatible parts in titanium, stainless steel, and specialty plastics, with tolerances down to ± .0002" and smooth surface finishes.
Swiss turning for small-diameter, high-precision biocompatible components with micro-sized features, ideal for minimally invasive device parts, bone screws, and slender surgical instruments.
Production-intent prototyping of biocompatible material components using the same machines and inspection equipment as final production, enabling direct scale-up with no re-qualification required.
Certified quality inspection with CMM, OASIS optical systems, and Keyence measuring systems, with no-charge Certificates of Conformance and final inspection reports for every biocompatible part.
Skilled machining of medical-grade titanium, 316L stainless steel, PEEK, cobalt-chrome, and specialty alloys—materials selected for body compatibility, corrosion resistance, and structural integrity.
Medical device manufacturers require more than tight tolerances—they need a machining partner who understands the regulatory, material, and performance demands of biocompatible components. At Criterion, our ISO 13485 and ISO 9001 certifications, FDA registration, and 70+ years of precision machining expertise mean every titanium, PEEK, or stainless steel part we produce is built to perform safely inside or alongside the human body. From prototypes to full production runs, we machine parts right the first time.
See how Criterion delivers mission-critical biocompatible components for leading medical device manufacturers.
We combine seven decades of machining heritage with the certifications and capabilities that medical device manufacturers demand.
Our ISO 13485 and ISO 9001 certifications ensure every biocompatible component meets stringent medical device quality management requirements.
We hold tolerances as tight as ± .0002" across titanium, PEEK, and stainless steel—critical for implantable and surgical-grade medical parts.
Criterion is FDA and ITAR registered, qualifying us to machine regulated biocompatible components for U.S. medical device OEMs and defense suppliers.
Founded in 1953 and now in its third generation, Criterion brings unmatched precision machining experience to Ohio's medical device supply chain.
Experienced professionals dedicated to precision, quality, and mission-critical manufacturing.
President
Tanya DiSalvo leads Criterion Precision Machining as its third-generation owner, continuing a family legacy that began in Brook Park, Ohio, in 1953. Under her leadership, Criterion has grown into a nationally recognized, woman-owned precision machining company serving the medical device, aerospace, defense, and photonics industries. Tanya's commitment to quality, investment in advanced CNC technology, and focus on a people-powered culture have positioned Criterion as a trusted partner for clients who require zero-failure components. Her guidance has driven the company's ISO 13485 and ISO 9001 certifications and its standing as a WBENC-certified Women's Business Enterprise.
Estimator/Project Manager
Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, acting as a key liaison between clients and the shop floor. With deep knowledge of CNC machining processes, materials, and production workflows, Mike translates complex biocompatible material requirements into accurate, competitive quotes and efficient production plans. His hands-on project management ensures that medical device components—from first-article prototypes to high-volume runs—are delivered on time, on spec, and fully documented to ISO 13485 standards. Mike's detail-oriented approach helps customers in the medical device sector move from design to delivery with confidence.
Chief Financial Officer
David Glass serves as Chief Financial Officer at Criterion Precision Machining, overseeing the financial operations that keep this 70-year-old precision machining company running at peak performance. His strategic financial oversight supports ongoing investment in advanced CNC equipment, quality systems, and the skilled workforce required to machine biocompatible materials to exacting medical standards. David's work ensures Criterion remains a financially stable, long-term partner for medical device OEMs and other mission-critical industries who depend on consistent supplier relationships for regulated components.
Quality Manager
Kelly Marflak is Criterion's Quality Manager and the guardian of the standards that define the company's reputation in biocompatible material machining. She oversees Criterion's certified Quality Assurance program, managing multiple inspection systems including the Global Advantage CMM, OASIS Optical Automatic Smart Inspection System, and Keyence measuring systems. Kelly ensures every medical device component produced at Criterion is inspected, documented, and compliant with ISO 13485 requirements. Her meticulous oversight means customers receive Certificates of Conformance and final inspection reports they can trust—every time.
Internal Systems Manager
Kellyanne Gottschalk manages Criterion's internal systems, including the ProShop ERP platform that keeps production, quality, and customer communication tightly integrated across all machining operations. Her role is critical to maintaining the traceability and documentation standards required in biocompatible material CNC machining, where regulatory compliance is non-negotiable. Kellyanne's work ensures that from the moment a medical device order enters the system to the moment it ships, every step is tracked, documented, and aligned with Criterion's ISO-certified quality management system.
Customer Service
Nilda Feliciano is Criterion's dedicated Customer Service representative, serving as the direct point of contact for medical device manufacturers and other clients throughout the order lifecycle. She ensures that communication is clear, timely, and proactive—keeping customers informed about order status, documentation, and delivery. Nilda's responsiveness and knowledge of Criterion's capabilities make it easy for new and returning clients to navigate the process of sourcing precision-machined biocompatible components, from initial inquiry through final delivery.
Office Administrator
Bonnie Paletta keeps Criterion's day-to-day office operations running smoothly, supporting the administrative functions that allow the shop floor and management team to focus on precision machining. Her organizational expertise and institutional knowledge—built over years at a company founded in 1953—help maintain the operational discipline that underpins Criterion's reputation for reliability in the medical device and aerospace sectors. Bonnie's behind-the-scenes contributions are essential to the consistent, on-time delivery performance Criterion's customers depend on.
What is an example of a biocompatible material?
Common biocompatible materials used in CNC machining include titanium (Grade 5 and Grade 23), medical-grade stainless steel (316L), PEEK (polyether ether ketone), cobalt-chrome alloys, and certain specialty plastics. These materials are chosen for their non-reactive properties, corrosion resistance, and ability to function safely in or near the human body.
What makes a material medical grade?
What is CNC in medical devices?
What certifications should a CNC machining shop have for medical device work?
Can Criterion machine titanium and PEEK for implantable device components?
What tolerances can Criterion hold on biocompatible material parts?
Does Criterion offer prototyping for medical device components before full production?
What documentation does Criterion provide with biocompatible machined parts?
Talk to our experts for a free consultation on your medical device component requirements.
Criterion ships precision-machined biocompatible components to medical device manufacturers across the United States.
Nationwide (U.S.)
Service Area
Brook Park, Ohio
Headquarters
Since 1953
In Business
Contact us to confirm we can fulfill your biocompatible machining requirements from your location.
Medical device quality management system certification.
International standard for quality management systems.
Women's Business Enterprise National Council certified.
Submit your part drawings, material specifications, and tolerance requirements. Our team will respond promptly with a detailed quote and project assessment tailored to your medical device program.
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