Medical Grade Manufacturing

Precision Manufacturing for Medical Devices.

Tight-tolerance components for orthopedic implants, surgical instruments, robotic navigation, and diagnostic equipment. ISO 13485:2016 certified. Made in the USA.

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ISO 13485:2016 · ISO 9001:2015 Certified
Made in USA
Clifton, NJ

By the Numbers

Tolerance: ±0.0004"
Quality Certified: ISO 13485:2016
ISO 9001:2015
Orthopedic Experience: 25+ Years
Lot Traceability: 100%

Cleanroom-ready finishes · Zero China dependency · Made in USA

Core Capabilities

Advanced machining for surgical-grade components.

Multi-axis CNC and EDM under one ISO 13485 quality system, supported by in-house finishing, inspection, and design.

CNC Milling

3, 4 & 5-axis precision milling

Complex 3, 4, and 5-axis milling for intricate orthopedic implants, bone plates, and surgical instrument housings.

Okuma Genos M560V full 5-axis
Bridgeport Conquest 480V full 4-axis
Tolerances to ±0.0004"

CNC Turning

Live-tooling, dual-spindle turning

High-precision turning for cylindrical components, bone screws, rods, and powered surgical tool drive shafts.

Dual Spindle live tooling turning centers
HAAS DS30 SSY 5-axis with live tooling
Micro parts down to 3mm diameter

Wire EDM

Zero-cutting-force precision

Ultra-precise cutting for complex geometries, splines, and delicate features in hardened medical-grade alloys.

Two Mitsubishi Electric MV1200S units
Zero cutting force on delicate parts
Exceptional surface finish capabilities

Sinker EDM

Blind cavities & sharp internal corners

Specialized electrical discharge machining for blind cavities, sharp internal corners, and complex 3D shapes.

Machining hardened tool steels and exotics
Custom EDM tooling and fixtures
Burr-free processing for critical components

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What We Make

Engineered for life-critical applications.

From orthopedic implants to robotic-surgery navigation, every component is manufactured under a dedicated medical-device quality system.

Explore medical specialization

Stainless surgical drill and reamer housings.

Surgical Instruments

Bone saws, drills, reamers & multi-component tools.

Bone screws and spherical orthopedic components.

Orthopedic Implants

Hip, knee, and spine hardware in Titanium and CoCr.

Diagnostic & Robotic

Endoscopy and robotic-navigation structural components.

Test Specimens

Porous titanium pucks and polymer test geometries.

Material Expertise

Biocompatible & exotic materials, mastered.

Titanium Grade 2/5/23
Stainless 304 / 316 / 17-4
Cobalt Chrome (CoCr)
PEEK Implantable
UHMWPE Joint Liners
Inconel High Temp
Tantalum Radiopaque
Tungsten High Density
ULTEM Autoclavable
Aluminum 6061 / 7075
Delrin Acetal
PTFE Low Friction
Titanium Grade 2/5/23
Stainless 304 / 316 / 17-4
Cobalt Chrome (CoCr)
PEEK Implantable
UHMWPE Joint Liners
Inconel High Temp
Tantalum Radiopaque
Tungsten High Density
ULTEM Autoclavable
Aluminum 6061 / 7075
Delrin Acetal
PTFE Low Friction

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The Precise Edge

Why leading medical OEMs choose us.

Requirement	Traditional Vendors	The Precise Edge
Quality Systems	Basic ISO 9001 or uncertified	ISO 13485:2016 Certified Dedicated medical device quality management
Precision & Tolerances	Standard commercial tolerances (±0.005")	Ultra-Precision (±0.0004") Critical for surgical instruments and implants
Material Traceability	Partial or manual tracking	100% Lot Control & Traceability From raw stock to finished component
Supply Chain Risk	Heavy reliance on single regions	Zero China Dependency Manufacturing across U.S., Europe & India
Production Scale	Rigid volume requirements	Seamless Scalability From rapid prototypes to mid-volume production

Quality Systems
Basic ISO 9001 or uncertified
ISO 13485:2016 Certified
Dedicated medical device quality management
Precision & Tolerances
Standard commercial tolerances (±0.005")
Ultra-Precision (±0.0004")
Critical for surgical instruments and implants
Material Traceability
Partial or manual tracking
100% Lot Control & Traceability
From raw stock to finished component
Supply Chain Risk
Heavy reliance on single regions
Zero China Dependency
Manufacturing across U.S., Europe & India
Production Scale
Rigid volume requirements
Seamless Scalability
From rapid prototypes to mid-volume production

16+

Part Families

±0.0004"

Tolerance

100%

Lot Traceability

Material Classes

Ready to engineer your next breakthrough?

Send us your STEP files and tolerance stack — we'll respond with a manufacturable quote.

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