ISO 13485 Certified Machine Shops

Find medical device manufacturing across 7 cities with 7+ ISO 13485 certified facilities

Certified Shops

Cities Nationwide

What is ISO 13485 Certification?

✓ FDA-Aligned Medical Standard

ISO 13485 is the international standard for quality management systems specific to medical device manufacturing. It ensures organizations meet regulatory requirements for safe and effective medical devices.

Medical device-specific quality requirements
FDA compliance and regulatory alignment
Risk management throughout product lifecycle
Sterility and contamination controls
Design controls and validation
Traceability and recall procedures

Why Choose ISO 13485 Certified Shops

FDA Compliance

Alignment with FDA regulations and international medical device standards for market approval

Risk Management

Comprehensive risk assessment and mitigation throughout the entire product lifecycle

Design Controls

Validated design and development processes ensuring safe and effective medical devices

Traceability & Recall

Complete product traceability and documented recall procedures for patient safety

Top Cities for ISO 13485 Machine Shops

Rank	City	State	ISO 13485 Shops
#1	CURTIS BAY	Maryland	1	View Shops →
#2	PLAINVILLE	Indiana	1	View Shops →
#3	SANTA CLARA	California	1	View Shops →
#4	MORGAN HILL	California	1	View Shops →
#5	COLORADO SPRINGS	Colorado	1	View Shops →
#6	Mesa	Arizona	1	View Shops →
#7	EAU CLAIRE	Wisconsin	1	View Shops →