When lives depend on the components you produce, precision isn't negotiable—it's essential. Criterion Precision Machining specializes in manufacturing mission-critical medical device components with tolerances as tight as ±.0002". With ISO 13485 certification and FDA registration, we deliver Swiss turning, CNC milling, and precision inspection services that meet the exacting standards of the medical device industry. From surgical instruments to implantable device components, our advanced manufacturing capabilities ensure every part performs flawlessly.
Comprehensive precision machining solutions for medical device manufacturers who demand absolute accuracy and regulatory compliance.
High-volume production of small-diameter medical components with tight tolerances down to ±.0002". Our multi-axis Swiss turning centers excel at producing slender, intricate parts with exceptional surface finishes for surgical instruments and implantable devices.
Multi-axis precision milling for complex medical components requiring intricate geometries. Our 3-, 4-, and 5-axis capabilities deliver consistent repeatability for critical applications in diagnostic equipment and surgical tools.
High-precision cylindrical and complex geometry medical parts machined to exacting tolerances. Specialized in challenging materials including titanium, stainless steels, and medical-grade plastics for implantable components and instruments.
Production-intent prototyping with the same precision and compliance standards as full production. Test fit, function, and manufacturability before scaling to high-volume production without reprogramming or re-qualification.
Certified quality assurance with Global Advantage CMM, OASIS optical inspection, and Keyence measuring systems. Complete documentation including Certificates of Conformance and inspection reports at no additional charge.
Specialized capabilities for micro-sized features and components with diameters as small as .010". Perfect for miniaturized medical devices requiring deep cuts, fine features, and exceptional precision on challenging materials.
Design Review & Material Selection
We begin by thoroughly analyzing your specifications, drawings, and tolerances. Our engineering team works with you to select optimal materials—whether titanium, stainless steel, PEEK, or specialty alloys—that meet both your performance requirements and FDA biocompatibility standards. This critical first step ensures manufacturability and regulatory compliance from the start.
Production-Intent Prototyping
Precision Machining with Advanced Technology
Multi-Point Quality Inspection
Documentation & Delivery
See how we've helped medical device companies achieve their most challenging precision machining requirements.
Seven decades of precision machining expertise focused exclusively on mission-critical medical applications.
ISO 13485 and ISO 9001 certified with FDA registration, ensuring your components meet all medical device manufacturing standards and regulatory requirements.
Tolerances as tight as ±.0002" with diameters down to .010", backed by advanced CMM inspection and optical measurement systems that verify every dimension.
Extensive experience machining titanium, medical-grade stainless steels, PEEK, and specialty alloys with complete material traceability and biocompatibility documentation.
Since 1953, we've evolved from a general machine shop to a specialized medical component manufacturer, combining generational expertise with cutting-edge Swiss turning and multi-axis CNC technology.
Experienced professionals dedicated to medical device manufacturing excellence.
President
As third-generation owner and President of Criterion Precision Machining, Tanya DiSalvo has positioned the company as a trusted partner in the medical device manufacturing industry. Under her leadership since taking the helm of this woman-owned business, Tanya has championed investments in advanced machining technology, rigorous quality systems, and ISO 13485 certification to meet the exacting demands of medical device OEMs. Her strategic vision focuses on the 'No Failure' sectors where precision isn't just preferred—it's essential for patient safety. Tanya's commitment to combining her family's seven-decade legacy of craftsmanship with modern manufacturing capabilities has made Criterion a preferred supplier for companies producing surgical instruments, implantable devices, and diagnostic equipment components. She actively maintains relationships with major medical device manufacturers and ensures Criterion stays at the forefront of regulatory compliance and quality standards.
Quality Manager
Kelly Marflak serves as Quality Manager at Criterion Precision Machining, overseeing all aspects of the company's ISO 13485 and ISO 9001 certified quality assurance program. With deep expertise in medical device quality systems and regulatory compliance, Kelly ensures every component meets the stringent standards required by the FDA and medical device industry. She manages Criterion's advanced inspection capabilities, including the Global Advantage CMM with PC-DMIS software, OASIS optical inspection system, and Keyence multi-dimensional measurement equipment. Kelly implements and maintains the multi-point inspection processes that verify dimensional accuracy, surface finish quality, and complete traceability throughout production. Her meticulous approach to documentation ensures customers receive comprehensive Certificates of Conformance, inspection reports, and material certifications. Kelly works closely with medical device manufacturers to understand their specific quality requirements and validation protocols, making her an invaluable partner in bringing life-saving devices to market.
Estimator/Project Manager
Mike Pinchot brings extensive technical expertise to his dual role as Estimator and Project Manager at Criterion Precision Machining. With comprehensive knowledge of Swiss turning, CNC milling, and precision machining processes, Mike serves as the primary technical liaison between customers and Criterion's manufacturing team. He conducts thorough design reviews, analyzes drawings and specifications, and provides accurate cost estimates for complex medical components. Mike's deep understanding of material properties—from titanium and stainless steels to medical-grade plastics and specialty alloys—enables him to recommend optimal solutions that balance manufacturability, performance, and cost. As Project Manager, he oversees component production from prototype through high-volume manufacturing, ensuring on-time delivery and adherence to exacting quality standards. Mike's proactive communication keeps medical device manufacturers informed throughout the production cycle, and his problem-solving abilities help navigate the technical challenges inherent in producing mission-critical components with tolerances as tight as ±.0002".
Medical device quality management system compliance
International quality management system standards
FDA registered medical device component manufacturer
Share your specifications and tolerances with us. We'll respond with a detailed quote and technical recommendations within 24-48 hours.
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