Medical Device Prototyping
Production-intent prototyping for medical devices with same precision and compliance standards as full production, enabling seamless transition to manufacturing.
Precision contract manufacturing for Class I, II, and III medical devices with FDA-compliant processes, ISO 13485 certification, and tolerances down to ±0.0002". From prototyping to full-scale production, we deliver mission-critical components that meet the highest regulatory standards for medical device manufacturers.
Comprehensive precision machining solutions for Class I, II, and III medical device components.
Production-intent prototyping for medical devices with same precision and compliance standards as full production, enabling seamless transition to manufacturing.
Specialized machining for small-diameter medical components with tolerances down to ±0.0002", ideal for surgical instruments and implantable device parts.
Multi-axis precision milling for complex medical device geometries, delivering consistent repeatability for critical healthcare applications.
High-precision turning for cylindrical medical components with tight tolerances, supporting diagnostic equipment and surgical instrument manufacturing.
Comprehensive inspection services with CMM technology and automated systems, ensuring full compliance with medical device quality standards.
Complete regulatory compliance support including documentation, traceability, and quality systems for Class I, II, and III medical devices.
Partner with a woman-owned precision manufacturer specializing in mission-critical medical device components. Our ISO 13485 certification, FDA registration, and advanced quality systems ensure your Class I, II, and III devices meet the strictest regulatory requirements. From titanium surgical instruments to PEEK implantable components, we deliver the reliability healthcare demands.
Supporting major medical device companies with precision components for over 70 years.
Seven decades of precision manufacturing excellence for mission-critical medical applications.
Full FDA registration and ISO 13485 certification for medical device manufacturing compliance.
Tolerances down to ±0.0002" with Swiss turning capabilities for the most demanding components.
Advanced CMM inspection, automated measurement systems, and comprehensive quality documentation for traceability.
WBENC certified woman-owned business providing diverse supplier opportunities for procurement requirements.
Experienced professionals driving medical device manufacturing excellence.
President
As third-generation owner and President of Criterion Precision Machining, Tanya DiSalvo leads a woman-owned company that has specialized in mission-critical manufacturing since 1953. Under her leadership, Criterion has evolved into a trusted partner for medical device manufacturers requiring the highest levels of precision and regulatory compliance. Tanya's vision has positioned the company as a leader in serving 'No Failure' industries, where component reliability is paramount. Her commitment to quality and innovation continues the family legacy while advancing the company's capabilities in advanced manufacturing technologies. Tanya ensures that Criterion maintains its ISO 13485 certification and FDA registration, critical for serving the medical device industry. Her leadership emphasizes both technological advancement and the human expertise that makes precision manufacturing possible.
Quality Manager
Kelly Marflak serves as Quality Manager at Criterion Precision Machining, overseeing the comprehensive quality systems essential for medical device manufacturing compliance. With expertise in ISO 13485 and FDA regulations, Kelly ensures that all manufacturing processes meet the stringent requirements of Class I, II, and III medical devices. She manages the company's advanced inspection capabilities, including Global Advantage CMM systems and automated measurement technologies that verify tolerances down to ±0.0002". Kelly's attention to detail and deep understanding of medical device quality standards ensures that every component meets the exacting specifications required for mission-critical healthcare applications. Her leadership in quality assurance provides manufacturers with the confidence that their components will perform reliably in life-saving medical devices. Kelly coordinates with regulatory bodies and maintains the documentation systems essential for medical device traceability and compliance.
Estimator/Project Manager
Mike Pinchot brings extensive project management expertise to Criterion Precision Machining as Estimator and Project Manager, specializing in complex medical device manufacturing projects. His deep understanding of precision machining processes enables accurate project scoping and timeline development for Class I, II, and III medical device components. Mike works closely with medical device manufacturers to understand their unique requirements, from initial prototyping through full-scale production. His expertise spans Swiss turning, CNC milling, and multi-axis machining applications critical for medical device manufacturing. Mike ensures that projects progress smoothly from initial quote through final delivery, maintaining the quality standards and regulatory compliance essential for medical applications. His project management approach emphasizes clear communication, milestone tracking, and proactive problem-solving to keep medical device development programs on schedule. Mike's estimating accuracy helps manufacturers plan their budgets effectively while ensuring no compromise on the precision required for healthcare applications.
What medical device classifications does Criterion manufacture components for?
We manufacture precision components for Class I, II, and III medical devices with full FDA registration and ISO 13485 certification ensuring compliance with all regulatory requirements.
What tolerances can you achieve for medical device components?
Do you provide prototyping services for medical devices?
What materials do you work with for medical applications?
How do you ensure quality and compliance for medical device manufacturing?
What is your minimum order quantity for medical device components?
Do you provide certificates of conformance and inspection reports?
What is your typical lead time for medical device components?
Connect with our team to discuss your precision manufacturing requirements.
Medical Device Quality Management
Quality Management System
Woman-Owned Business Enterprise
Get expert guidance on precision manufacturing solutions for your Class I, II, or III medical device 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