Swiss Turning
Complex medical components with tight tolerances down to ±0.0002 inches for small-diameter, high-volume production of surgical instruments and implantable device parts.
Partner with Criterion Precision Machining for mission-critical medical device components that meet FDA standards and ISO 13485 requirements. Our advanced Swiss turning, CNC milling, and quality inspection capabilities deliver the exacting tolerances and consistent reliability your medical devices demand, ensuring patient safety and regulatory compliance.
Complete manufacturing solutions for medical device components with FDA compliance and ISO 13485 certification.
Complex medical components with tight tolerances down to ±0.0002 inches for small-diameter, high-volume production of surgical instruments and implantable device parts.
Precision 3-, 4-, and 5-axis milling for intricate medical device housings, brackets, and complex multi-axis components requiring exceptional accuracy.
High-precision cylindrical medical components including pins, rods, and complex geometry parts for surgical and diagnostic equipment applications.
Production-intent prototyping for medical devices, testing fit, function, and manufacturability before full-scale production with same quality standards.
Comprehensive quality assurance with CMM inspection, optical measurement systems, and complete documentation including Certificates of Conformance.
Criterion Precision Machining delivers mission-critical medical device components with exacting tolerances where failure is not an option. Our FDA-registered facility combines advanced Swiss turning and multi-axis CNC capabilities with rigorous quality systems to ensure your surgical instruments, implantable devices, and diagnostic equipment meet the highest medical industry standards and regulatory requirements.
Serving leading medical device manufacturers with precision components for critical applications.
Over 70 years of precision manufacturing excellence serving mission-critical medical device applications.
FDA registered facility with ISO 13485 and ISO 9001 certifications ensuring regulatory compliance.
Tight tolerances down to ±0.0002 inches with advanced CMM inspection and quality documentation.
Swiss turning, 5-axis CNC milling, and optical inspection systems for complex medical components.
Woman-owned business with 70+ years serving medical device manufacturers like Smith & Nephew.
Expert leadership driving medical manufacturing excellence since 1953.
President
As the third-generation owner of Criterion Precision Machining, Tanya DiSalvo leads the company's mission to serve 'No Failure' industries with uncompromising precision. Under her leadership, Criterion has strengthened its position as a trusted partner for medical device manufacturers, investing in advanced technology and quality systems that meet the most stringent industry requirements. Tanya's commitment to excellence ensures every component meets the exacting standards demanded by surgical instruments, implantable devices, and diagnostic equipment. Her vision drives the company's continued growth in serving mission-critical applications where precision and reliability are non-negotiable, maintaining the legacy of quality that has defined Criterion since 1953.
Quality Manager
Kelly Marflak oversees Criterion's comprehensive quality assurance program, ensuring every medical device component meets the rigorous standards required for FDA compliance and ISO 13485 certification. With expertise in advanced inspection technologies including CMM measurement and optical inspection systems, Kelly maintains the quality protocols that make Criterion a trusted partner for medical device manufacturers. Her meticulous approach to quality control ensures that surgical instruments, implantable device components, and diagnostic equipment parts consistently meet tolerances down to ±0.0002 inches. Kelly's commitment to quality excellence provides medical device manufacturers with the confidence that their mission-critical components will perform flawlessly in life-saving applications.
Estimator/Project Manager
Mike Pinchot brings extensive project management expertise to medical device manufacturing projects, ensuring seamless coordination from initial prototyping through full production runs. His deep understanding of medical industry requirements enables accurate project estimation and timeline management for complex surgical instruments and implantable device components. Mike works closely with medical device manufacturers to understand their specific needs, coordinating Swiss turning, CNC milling, and quality inspection processes to deliver components that meet exacting medical standards. His project management approach ensures that critical medical device components are delivered on schedule while maintaining the quality and compliance standards essential for patient safety and regulatory approval.
What medical device components can Criterion manufacture?
We specialize in surgical instruments, implantable device components, diagnostic equipment parts, and other precision medical components requiring tight tolerances and FDA compliance.
Do you have medical industry certifications?
What tolerances can you achieve for medical components?
Can you handle medical device prototyping?
What materials do you work with for medical devices?
Do you provide quality documentation?
What is your experience with medical device manufacturers?
Can you handle both small and large volume medical device orders?
Connect with our medical manufacturing experts for a detailed consultation and quote.
Medical device quality management certification
Quality management systems certification
Registered medical device manufacturing facility
Get expert guidance and a detailed quote for your precision medical component needs.
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