Criterion Precision Machining delivers mission-critical medical plastics machining with tolerances down to ±.0002". ISO 13485 certified and FDA registered, we specialize in PEEK, Ultem, and specialty medical-grade polymers for implantable devices, surgical instruments, and diagnostic equipment. Our advanced CNC capabilities ensure biocompatibility, sterility compliance, and zero-defect manufacturing for components where failure is not an option in healthcare applications.
Comprehensive precision CNC solutions for medical-grade plastics, from prototyping through full production with ISO 13485 compliance.
Micro-precision Swiss turning for small-diameter medical plastic components with tolerances to ±.0002". Ideal for catheter components, micro-surgical instruments, and implantable device parts requiring exceptional surface finishes and complex geometries in PEEK, Ultem, and specialty medical polymers.
3-, 4-, and 5-axis CNC milling for complex medical plastic components including surgical instrument housings, diagnostic equipment parts, and orthopedic device components. Precision machining of intricate features, pockets, and contours in medical-grade thermoplastics with consistent repeatability.
High-precision CNC turning for cylindrical medical plastic parts including connector bodies, valve components, and device housings. Multi-axis capabilities for complex geometries with live tooling for secondary operations, ensuring tight tolerances and smooth surface finishes critical for medical applications.
Production-intent prototyping for medical plastic components using the same equipment and quality standards as full production. Test fit, function, and biocompatibility with meaningful prototype runs that provide real-world performance data before scaling to volume manufacturing.
ISO 13485 compliant inspection with CMM measurement, optical inspection systems, and comprehensive documentation. Includes Certificates of Conformance, material certifications, dimensional reports, and full traceability for FDA-regulated medical device components.
Ultra-precision machining capabilities achieving tolerances down to ±.0002" on medical-grade plastics. Critical for implantable components, mating parts, and assemblies requiring exact dimensional control. Advanced metrology ensures every dimension meets or exceeds specifications.
When medical device manufacturers need precision-machined plastic components, they turn to Criterion. Our FDA-registered facility specializes in machining medical-grade polymers like PEEK, Ultem, and specialty plastics with tolerances to ±.0002". From implantable device components to surgical instruments and diagnostic equipment, we deliver zero-defect manufacturing backed by ISO 13485 certification and comprehensive quality documentation. Every part is produced on advanced CNC equipment with full traceability and compliance support.
Leading medical device manufacturers rely on Criterion for mission-critical plastic components that demand absolute precision and regulatory compliance.
Delivering mission-critical medical plastics machining with three generations of precision manufacturing excellence.
FDA-registered facility with ISO 13485 and ISO 9001 certifications ensuring full regulatory compliance for medical device manufacturing.
Tolerances down to ±.0002" with Swiss turning capabilities for diameters as small as .010" in medical-grade plastics and specialty polymers.
Comprehensive quality documentation with CMM inspection reports, material certifications, Certificates of Conformance, and complete lot traceability for regulated medical components.
Third-generation, woman-owned business (WBENC certified) with 70+ years serving 'No Failure' industries including medical devices, aerospace, and defense.
Experienced professionals dedicated to precision medical manufacturing excellence.
President
As President and third-generation owner of Criterion Precision Machining, Tanya DiSalvo leads the company's strategic vision in serving mission-critical industries. Under her leadership, Criterion has strengthened its position as a trusted partner for medical device manufacturers requiring precision-machined components with exacting tolerances. Tanya has championed investments in advanced CNC technology, ISO 13485 certification, and FDA registration to meet the evolving demands of the medical device sector. Her commitment to quality, compliance, and customer partnership has positioned Criterion as a woman-owned leader in precision machining for 'No Failure' industries. She maintains the company's founding values of craftsmanship and reliability while embracing modern manufacturing technologies and quality systems that ensure every component meets the highest standards for medical applications.
Quality Manager
Kelly Marflak serves as Quality Manager at Criterion Precision Machining, overseeing the company's ISO 13485 and ISO 9001 certified quality management systems. With deep expertise in medical device quality requirements and regulatory compliance, Kelly ensures every component meets stringent specifications and documentation standards. She leads the quality assurance team in implementing precision inspection protocols using advanced metrology equipment including CMM systems with PC-DMIS software, optical inspection systems, and multi-dimensional measurement tools. Kelly's rigorous approach to quality control has been instrumental in maintaining Criterion's reputation for zero-defect manufacturing in mission-critical applications. She develops and maintains inspection procedures, validates measurement systems, and ensures full traceability for FDA-regulated components. Her commitment to continuous improvement and compliance excellence provides medical device manufacturers with the confidence that every part meets or exceeds specifications with complete documentation and material certification.
Estimator/Project Manager
Mike Pinchot serves as Estimator and Project Manager at Criterion Precision Machining, bringing extensive expertise in precision machining project planning and execution for medical device components. He works closely with medical device manufacturers to understand their unique requirements, from tight tolerances and material specifications to regulatory documentation needs. Mike's technical knowledge of CNC machining processes, including Swiss turning, multi-axis milling, and specialty plastics machining, enables him to provide accurate project estimates and realistic timelines. He coordinates production workflows, manages customer expectations, and ensures seamless communication from initial quote through final delivery. His attention to detail and understanding of medical device quality requirements helps customers navigate the complexities of precision plastic component manufacturing. Mike's project management approach focuses on meeting critical deadlines while maintaining the exacting quality standards required for FDA-regulated components, making him a trusted partner for medical device manufacturers seeking reliable, precision-machined plastic parts.
What types of medical-grade plastics can you machine with precision CNC?
Criterion specializes in machining medical-grade polymers including PEEK (polyetheretherketone), Ultem (polyetherimide), polycarbonate, acetal, and other specialty plastics approved for medical device applications. We have extensive experience with materials requiring biocompatibility, chemical resistance, and sterilization capability for implantable devices, surgical instruments, and diagnostic equipment components.
What tolerances can you achieve on medical plastic components?
Are you ISO 13485 certified and FDA registered?
Can you provide prototyping services for medical plastic components?
What size medical plastic components can you manufacture?
What quality documentation do you provide with medical plastic parts?
What is your typical lead time for medical plastic machining projects?
Do you handle secondary operations and finishing for medical plastics?
Connect with our technical team to explore how our precision CNC capabilities can meet your medical device component requirements.
Medical device quality management system certification
International quality management standard certification
Women's Business Enterprise National Council member
Share your specifications and requirements. Our team will provide a detailed quote with timeline and technical recommendations for your medical-grade plastic components.
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