ISO 13485 Certified Machine Shops
Find ISO 13485 certified precision manufacturers across 6 states with 7+ verified facilities
What is ISO 13485 Certification?
ISO 13485 is the quality management system standard for medical device manufacturing. It specifies requirements for organizations to demonstrate their ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
FDA Ready
Quality systems aligned with FDA 21 CFR Part 820 requirements
Medical Grade
Specialized processes for biocompatible materials and clean manufacturing
Full Traceability
Complete documentation and lot traceability for medical devices
Risk Management
Integrated risk management throughout the product lifecycle
ISO 13485 Machine Shops by State
Select a state to find ISO 13485 certified machine shops in your area
| Rank | State | ISO 13485 Shops | Cities | |
|---|---|---|---|---|
| #1 | California | 2 | 2 | View Shops → |
| #2 | Maryland | 1 | 1 | View Shops → |
| #3 | Indiana | 1 | 1 | View Shops → |
| #4 | Colorado | 1 | 1 | View Shops → |
| #5 | Arizona | 1 | 1 | View Shops → |
| #6 | Wisconsin | 1 | 1 | View Shops → |
Industries Requiring ISO 13485
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