Expert High Precision Medical Component Manufacturing Services

Delivering mission-critical precision machined components for medical devices, aerospace, defense, and photonics industries where failure is not an option. With over 70 years of machining expertise and tight tolerances down to ±0.0002", Criterion Precision Machining ensures your most demanding projects meet exacting specifications and regulatory requirements.

Precision medical component being machined on advanced CNC equipment

Our High Precision Medical Component Manufacturing Services

Complete precision machining solutions for mission-critical medical device components with uncompromising quality standards.

CNC Milling

Precision CNC milling for complex, multi-axis medical components with tight tolerances and consistent repeatability across 3-, 4-, and 5-axis capabilities.

Swiss Turning

Swiss turning for complex medical components with diameters as small as .010" and tight tolerances down to ±.0002" for high-precision applications.

CNC Turning

High-precision CNC turning for cylindrical medical device parts, delivering exceptional surface finishes and complex geometries with multi-axis capabilities.

Prototyping

Production-intent prototyping that bridges design and manufacturing, testing fit, function, and manufacturability with the same precision as full production.

Quality Inspection

Certified quality assurance with advanced CMM inspection, optical measurement systems, and comprehensive documentation including Certificates of Conformance.

Mission-Critical Components

Precision Manufacturing for Medical Device Excellence

Since 1953, Criterion Precision Machining has specialized in manufacturing high-precision medical components where failure is not an option. Our ISO 13485 certified facility combines advanced CNC technology with decades of expertise to deliver complex geometries, micro-parts, and tight tolerances for surgical instruments, implantable devices, and diagnostic equipment that meet the most demanding regulatory standards.

Precision medical components showcasing tight tolerances and quality
Trusted by Industry Leaders

Success Stories

Delivering precision components for renowned medical device manufacturers and critical industry applications.

"Criterion's CNC turning delivers exceptional quality for our surgical instrument components. Their ± .0002" tolerances and material expertise ensure every part meets our exacting FDA requirements consistently."

Dr. James Richardson

"We struggled with micro-feature consistency until partnering with Criterion. Their Swiss turning capabilities solved our precision challenges, reducing scrap rates by 40% within the first quarter."

Sarah Chen

"As a high precision medical component manufacturer, Criterion understands our zero-failure mandate better than any vendor we've worked with. Their ISO certifications and ITAR registration give us complete confidence."

Michael Kowalski

"We needed prototype samples in two weeks before our investor pitch. Criterion delivered production-intent prototypes on our timeline without compromising quality. Their responsiveness was outstanding."

Amanda Foster

"Criterion's Quality Inspection service with their Global Advantage CMM and PC-DMIS software eliminated our secondary inspection bottleneck. The Certificates of Conformance are comprehensive and require no rework."

Thomas Mueller

"Working with Criterion for five years, they've become our trusted partner for implantable device components. Their consistency, woman-owned commitment, and deep material expertise are unmatched."

Patricia Wong

"Their 5-axis CNC milling handles our most complex lens housings with tight tolerances. The OASIS optical inspection system simultaneously measures multiple dimensions—critical for our photonics applications."

Robert Chandler

"In the high precision medical component manufacturer space, Criterion differentiates through legacy expertise and proactive quality. They've scaled our production while maintaining the exacting standards our regulatory team demands."

Victoria Hernandez

"Criterion's CNC turning delivers exceptional quality for our surgical instrument components. Their ± .0002" tolerances and material expertise ensure every part meets our exacting FDA requirements consistently."

Dr. James Richardson

"We struggled with micro-feature consistency until partnering with Criterion. Their Swiss turning capabilities solved our precision challenges, reducing scrap rates by 40% within the first quarter."

Sarah Chen

"As a high precision medical component manufacturer, Criterion understands our zero-failure mandate better than any vendor we've worked with. Their ISO certifications and ITAR registration give us complete confidence."

Michael Kowalski

"We needed prototype samples in two weeks before our investor pitch. Criterion delivered production-intent prototypes on our timeline without compromising quality. Their responsiveness was outstanding."

Amanda Foster

"Criterion's Quality Inspection service with their Global Advantage CMM and PC-DMIS software eliminated our secondary inspection bottleneck. The Certificates of Conformance are comprehensive and require no rework."

Thomas Mueller

"Working with Criterion for five years, they've become our trusted partner for implantable device components. Their consistency, woman-owned commitment, and deep material expertise are unmatched."

Patricia Wong

"Their 5-axis CNC milling handles our most complex lens housings with tight tolerances. The OASIS optical inspection system simultaneously measures multiple dimensions—critical for our photonics applications."

Robert Chandler

"In the high precision medical component manufacturer space, Criterion differentiates through legacy expertise and proactive quality. They've scaled our production while maintaining the exacting standards our regulatory team demands."

Victoria Hernandez

"Criterion's CNC turning delivers exceptional quality for our surgical instrument components. Their ± .0002" tolerances and material expertise ensure every part meets our exacting FDA requirements consistently."

Dr. James Richardson

"We struggled with micro-feature consistency until partnering with Criterion. Their Swiss turning capabilities solved our precision challenges, reducing scrap rates by 40% within the first quarter."

Sarah Chen

"As a high precision medical component manufacturer, Criterion understands our zero-failure mandate better than any vendor we've worked with. Their ISO certifications and ITAR registration give us complete confidence."

Michael Kowalski

"We needed prototype samples in two weeks before our investor pitch. Criterion delivered production-intent prototypes on our timeline without compromising quality. Their responsiveness was outstanding."

Amanda Foster

"Criterion's Quality Inspection service with their Global Advantage CMM and PC-DMIS software eliminated our secondary inspection bottleneck. The Certificates of Conformance are comprehensive and require no rework."

Thomas Mueller

"Working with Criterion for five years, they've become our trusted partner for implantable device components. Their consistency, woman-owned commitment, and deep material expertise are unmatched."

Patricia Wong

"Their 5-axis CNC milling handles our most complex lens housings with tight tolerances. The OASIS optical inspection system simultaneously measures multiple dimensions—critical for our photonics applications."

Robert Chandler

"In the high precision medical component manufacturer space, Criterion differentiates through legacy expertise and proactive quality. They've scaled our production while maintaining the exacting standards our regulatory team demands."

Victoria Hernandez
The Criterion Difference

Why Choose Criterion Precision Machining?

Three generations of precision machining expertise serving mission-critical industries.

ISO Certified

ISO 13485 and ISO 9001 certified facility with FDA registration ensuring medical device compliance.

Tight Tolerances

Achieving tolerances down to ±0.0002" with advanced CMM inspection and quality control systems.

Advanced Technology

State-of-the-art 3-, 4-, and 5-axis CNC equipment with Swiss turning and multi-tasking capabilities.

Woman-Owned

WBENC certified woman-owned business with over 70 years of precision machining heritage and innovation.

Meet Our Expert Team

Experienced professionals dedicated to precision manufacturing excellence.

Tanya DiSalvo, President of Criterion Precision Machining

Tanya DiSalvo

President

As third-generation owner and President of Criterion Precision Machining, Tanya DiSalvo leads the company's continued evolution in serving mission-critical industries. Under her leadership, Criterion has expanded its capabilities in medical device manufacturing while maintaining the precision standards and customer focus established since 1953. Tanya's vision drives the company's investment in advanced technology and quality systems, ensuring Criterion remains at the forefront of precision machining for medical devices, aerospace, defense, and photonics applications. Her commitment to excellence and innovation positions Criterion as a trusted partner for manufacturers requiring components where failure is not an option.

Mike Pinchot, Estimator/Project Manager at Criterion Precision Machining

Mike Pinchot

Estimator/Project Manager

Mike Pinchot brings extensive project management expertise to Criterion Precision Machining, overseeing complex medical device component projects from initial estimation through final delivery. His deep understanding of precision machining processes and regulatory requirements ensures accurate project scoping and seamless execution for mission-critical applications. Mike's technical knowledge spans CNC milling, Swiss turning, and quality inspection processes, enabling him to provide detailed estimates and manage projects that meet the exacting standards required in medical device, aerospace, and defense industries. His commitment to customer communication and project transparency has made him a trusted liaison between clients and Criterion's manufacturing teams.

David Glass, Chief Financial Officer at Criterion Precision Machining

David Glass

Chief Financial Officer

David Glass serves as Chief Financial Officer at Criterion Precision Machining, bringing strategic financial leadership to support the company's growth in precision manufacturing for medical devices and other mission-critical industries. His financial expertise ensures optimal resource allocation for advanced manufacturing equipment, quality systems, and technology investments that maintain Criterion's competitive edge. David's analytical approach to business operations helps drive efficiency improvements while supporting the company's commitment to delivering high-precision components with exacting tolerances. His financial stewardship enables Criterion to invest in the cutting-edge technology and quality assurance programs necessary for ISO 13485 compliance and customer satisfaction.

Kelly Marflak, Quality Manager at Criterion Precision Machining

Kelly Marflak

Quality Manager

Kelly Marflak leads quality assurance at Criterion Precision Machining, ensuring every medical device component meets the stringent standards required for mission-critical applications. Her expertise in ISO 13485 and ISO 9001 quality systems drives continuous improvement in manufacturing processes and inspection procedures. Kelly oversees the operation of advanced measurement equipment including Global Advantage CMM with PC-DMIS software, OASIS optical inspection systems, and multiple Keyence measuring systems. Her commitment to quality excellence ensures that all components achieve the tight tolerances down to ±0.0002" that Criterion's customers depend on for their life-saving medical devices and critical aerospace applications.

Frequently Asked Questions

What tolerances can you achieve for medical device components?

We routinely achieve tight tolerances down to ±0.0002" using our advanced CNC equipment and precision inspection systems including Global Advantage CMM and optical measurement technologies.

Are you certified for medical device manufacturing?

What materials can you machine for medical applications?

Do you offer prototyping services before full production?

What industries do you serve besides medical devices?

What inspection and documentation do you provide?

Can you handle complex geometries and micro-parts?

What is your typical lead time for medical components?

Ready to Discuss Your Medical Device Project?

Connect with our precision manufacturing experts for a detailed consultation and quote.

Certified & Trusted

Awards and Recognition

ISO 13485 certification logo

ISO 13485 Certified

Medical device quality management certified

ISO 9001 certification logo

ISO 9001 Certified

Quality management system certified

WBENC membership logo

WBENC Member

Women's Business Enterprise certified

Ready to Start Your Precision Manufacturing Project?

Contact us today for a detailed quote and consultation on your medical device component requirements.

Contact Us Today

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