CNC Milling
Precision 3-, 4-, and 5-axis CNC milling of PEEK for complex medical device components, achieving intricate geometries and tight tolerances with consistent, repeatable results across every production run.
Medical devices demand materials that perform without compromise—PEEK delivers the biocompatibility, strength, and chemical resistance surgeons and engineers rely on. At Criterion Precision Machining, we apply over 70 years of precision manufacturing expertise and ISO 13485-certified quality systems to machine PEEK components to tolerances as tight as ±.0002", ensuring every part meets the exacting standards your application requires.
From prototyping to full production, we deliver precision-machined PEEK components for medical devices with certified quality at every step.
Precision 3-, 4-, and 5-axis CNC milling of PEEK for complex medical device components, achieving intricate geometries and tight tolerances with consistent, repeatable results across every production run.
High-precision CNC turning of PEEK for cylindrical and complex-geometry medical parts, with tolerances down to ±.0002" and smooth surface finishes critical for implantable and surgical device applications.
Multi-axis Swiss turning for small-diameter, high-precision PEEK components used in minimally invasive instruments and micro-sized medical device parts requiring exceptional surface quality and dimensional accuracy.
Production-intent PEEK prototyping built to the same standards as full-production orders—enabling design validation, fit-and-function testing, and a seamless transition to higher-volume medical device manufacturing.
ISO 13485-certified inspection using CMM, OASIS optical systems, and Keyence measurement technology to verify every PEEK component meets precise dimensional and documentation requirements—at no extra charge.
Deep expertise machining unfilled and filled-grade PEEK variants for medical applications, ensuring optimal tool paths, chip evacuation strategies, and finishing techniques that preserve PEEK's critical material properties.
Design Review & Application Engineering
Our team analyzes your medical device drawings and specifications, flagging any design-for-manufacturability concerns specific to PEEK's unique machining characteristics before a single chip is cut—reducing costly revisions downstream.
Material Selection & Sourcing
Precision CNC Machining
Multi-Point Quality Inspection
Documentation & Delivery
See how Criterion delivers mission-critical PEEK components that meet the highest medical device standards.
When your medical device cannot afford a single failure, you need a machining partner whose quality systems, expertise, and track record are beyond question.
Our ISO 13485 and ISO 9001 certifications—plus FDA registration—ensure your PEEK components meet rigorous medical device quality and regulatory standards.
Founded in 1953 and now in its third generation, Criterion brings decades of institutional knowledge machining challenging materials for life-critical industries.
Our advanced CNC milling, turning, and Swiss turning capabilities routinely achieve tolerances down to ±.0002" on complex PEEK geometries—exactly what medical devices demand.
Multi-point inspection using CMM, OASIS optical systems, and Keyence equipment guarantees dimensional conformance, with full documentation provided at no extra cost.
Experienced professionals dedicated to precision, quality, and mission-critical outcomes.
President
Tanya DiSalvo leads Criterion Precision Machining as its third-generation owner, carrying forward a legacy of precision excellence that began in Brook Park, Ohio in 1953. Under her leadership, Criterion has earned ISO 13485 and ISO 9001 certifications, secured FDA and ITAR registration, and deepened its specialization in mission-critical industries including medical devices, aerospace, defense, and photonics. As a WBENC-certified woman-owned business, Criterion reflects Tanya's commitment to both technical excellence and inclusive leadership. She has guided the company through significant investments in advanced machining technology and quality systems, ensuring Criterion remains a trusted precision partner for clients like Smith & Nephew, Corning, and Riverpoint Medical who demand components where failure is never an option.
Estimator/Project Manager
Mike Pinchot serves as Criterion's Estimator and Project Manager, acting as the central point of contact between clients and the shop floor. Mike translates complex medical device component requirements—including tight-tolerance PEEK machining specifications—into accurate, competitive quotes and actionable production plans. His cross-functional role ensures that customer expectations around lead times, material traceability, and documentation requirements are clearly communicated and consistently met. With deep familiarity across Criterion's Swiss turning, CNC turning, and multi-axis milling capabilities, Mike is instrumental in identifying the most efficient and cost-effective machining strategies for new programs—particularly for medical device customers navigating prototype-to-production transitions.
Quality Manager
Kelly Marflak oversees Criterion's ISO 13485-certified Quality Assurance program, ensuring that every PEEK component and medical device part leaving the facility meets or exceeds customer and regulatory specifications. Kelly manages Criterion's multi-point inspection infrastructure—including the Global Advantage CMM with PC-DMIS software, the OASIS Optical Automatic Smart Inspection System, and Keyence multi-dimension measurement systems—that together provide unmatched dimensional verification capabilities. Her leadership ensures that quality is built into every stage of the manufacturing process, not just verified at the end. Kelly also oversees the preparation of Certificates of Conformance, final inspection reports, and other documentation critical to medical device supply chain compliance.
Is PEEK easily machinable?
PEEK (Polyether Ether Ketone) is considered machinable compared to many engineering plastics, but it requires proper tooling, speeds, feeds, and chip evacuation strategies to achieve optimal results. Its semi-crystalline structure can cause tool wear if not managed correctly. At Criterion, our experienced machinists have refined proven processes for PEEK, routinely achieving tolerances as tight as ±.0002" and excellent surface finishes for medical device applications.
Can you CNC machine PEEK?
What PEEK grades do you machine for medical devices?
What tolerances can you hold on PEEK medical components?
Are you ISO 13485 certified for medical device machining?
Do you offer PEEK prototyping before full production?
What documentation do you provide with PEEK medical device components?
What is your typical lead time for PEEK machined components?
Talk to our engineering team for a free consultation on your medical device component requirements.
Criterion ships precision-machined PEEK medical device components to customers across the United States from our Brook Park, Ohio facility.
Nationwide USA
Service Area
Brook Park, Ohio
Headquarters
Medical & More
Industries Served
We ship precision PEEK components to medical device customers across the United States.
Medical device quality management system certification ensuring rigorous process control.
International standard for quality management systems across all operations.
Women's Business Enterprise National Council certified woman-owned business.
Share your drawings and specifications with our team. We'll review your requirements and respond with a precise quote, lead time estimate, and any application engineering recommendations—typically within one business day.
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