Swiss Turning
Ultra-precise Swiss turning for small-diameter medical components with tolerances down to ±0.0002" and exceptional surface finishes.
Criterion Precision Machining delivers mission-critical medical components with exacting tolerances down to ±0.0002". Our ISO 13485 certified facility combines 70+ years of expertise with advanced Swiss turning, 5-axis milling, and quality assurance programs to ensure zero-failure performance for medical device manufacturers.
Comprehensive precision machining solutions for mission-critical medical device components.
Ultra-precise Swiss turning for small-diameter medical components with tolerances down to ±0.0002" and exceptional surface finishes.
Advanced 3-, 4-, and 5-axis milling for complex medical geometries requiring tight tolerances and consistent repeatability.
High-precision turning for cylindrical medical components with complex geometries and smooth surface finishes in challenging materials.
Production-intent prototyping for surgical instruments, implantable devices, and diagnostic equipment with full compliance testing.
Certified quality assurance with CMM inspection, dimensional analysis, and complete documentation including Certificates of Conformance.
Specialized machining of medical-grade titanium, stainless steels, PEEK, and other biocompatible materials for critical applications.
When medical device manufacturers need components that perform flawlessly, they trust Criterion's 70+ years of precision machining expertise. Our ISO 13485 certified facility delivers surgical instruments, implantable device components, and diagnostic equipment parts with tolerances down to ±0.0002". Every component undergoes rigorous quality inspection using advanced CMM technology and comprehensive documentation to ensure regulatory compliance and patient safety.
Trusted by leading medical device manufacturers for mission-critical components.
Decades of expertise delivering mission-critical medical components with zero-failure performance.
ISO 13485 and ISO 9001 certified quality management systems for medical device manufacturing.
Tolerances down to ±0.0002" with advanced Swiss turning and multi-axis machining capabilities.
Specialized in biocompatible materials and FDA-regulated medical device component manufacturing.
Advanced CMM inspection with complete documentation and Certificates of Conformance included at no charge.
Expert professionals dedicated to precision and quality.
President
As President of Criterion Precision Machining, Tanya DiSalvo leads the third generation of family ownership, continuing the legacy of precision machining excellence that began in 1953. Under her leadership, Criterion has evolved into a specialized manufacturer serving mission-critical industries including medical devices, aerospace, defense, and photonics. Tanya has championed the company's ISO certification initiatives and commitment to zero-failure performance standards. Her vision has guided Criterion's investment in advanced Swiss turning technology, multi-axis CNC equipment, and state-of-the-art quality inspection systems. As a woman-owned business leader, she has positioned Criterion as a trusted partner for medical device manufacturers requiring exacting tolerances and regulatory compliance. Tanya's dedication to continuous improvement and customer success has established Criterion as a leader in precision machining for industries where failure is not an option.
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 extensive experience in medical device manufacturing quality standards, Kelly ensures that every component meets the exacting requirements of FDA-regulated industries. She manages Criterion's comprehensive quality assurance program, including the operation of advanced CMM inspection equipment, dimensional analysis protocols, and documentation systems. Kelly's expertise encompasses statistical process control, regulatory compliance, and continuous improvement initiatives that maintain Criterion's reputation for zero-failure performance. Under her guidance, the quality team utilizes Global Advantage CMM with PC-DMIS software, OASIS optical inspection systems, and Keyence measuring technology to verify tolerances down to ±0.0002". Kelly's commitment to quality excellence ensures that medical device manufacturers receive components with complete traceability, Certificates of Conformance, and the reliability required for patient safety applications.
Estimator/Project Manager
Mike Pinchot brings extensive project management and estimation expertise to Criterion Precision Machining as Estimator and Project Manager. With deep knowledge of precision machining processes and medical device manufacturing requirements, Mike works closely with customers to develop accurate project estimates and ensure successful execution from prototype to production. His experience encompasses complex Swiss turning projects, multi-axis milling operations, and the unique challenges of machining medical-grade materials including titanium, stainless steels, and specialty plastics. Mike coordinates with Criterion's engineering and quality teams to optimize manufacturing processes while maintaining the tight tolerances and surface finishes required for medical applications. His project management approach ensures on-time delivery and cost-effective solutions for medical device manufacturers seeking reliable precision machining partners. Mike's technical expertise and customer focus have made him instrumental in building long-term relationships with companies requiring mission-critical components where quality and reliability are paramount.
What medical device certifications does Criterion hold?
Criterion is ISO 13485 certified for medical device quality management systems and ISO 9001 certified for general quality management. We are also FDA registered and maintain strict compliance with medical device manufacturing regulations.
What tolerances can you achieve for medical components?
Do you provide documentation for medical device components?
What materials do you machine for medical applications?
Can you handle prototype development for medical devices?
What is your typical lead time for medical components?
Do you offer secondary operations for medical components?
What industries do you serve besides medical devices?
Speak with our medical device specialists about your precision machining requirements.
Medical device quality management certification
Quality management system certification
Women's Business Enterprise certified
Contact our medical device specialists for a detailed quote and project consultation.
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