ISO 13485 Certified Machine Shops
Find medical device manufacturing across 5 cities with 6+ ISO 13485 certified facilities
6+
Certified Shops
5
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 | Mesa | Arizona | 2 | View Shops → |
| #2 | SCITUATE | Massachusetts | 1 | View Shops → |
| #3 | CUMBERLAND | Rhode Island | 1 | View Shops → |
| #4 | MINNEAPOLIS | Minnesota | 1 | View Shops → |
| #5 | FAIRVIEW | Pennsylvania | 1 | View Shops → |
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