Quality & Regulatory Downloads
International Regulatory Compliance Information
We are US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 certified Manufacturers.
We assist our customers with all of their regulatory requirements.
Quality Management System
| Indianapolis | ISO 13485 Quality System Certificate |
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US FDA Quality Systems Regulations (QSR)
| U.S. Food and Drug Administration | BiomericsATL Indianapolis Registration Number: 1833117 BiomericsATL Costa Rica Registration Number: 3014246639 |
Search FDA |
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International Certifications
| Europe EC Certificates | EC Certificate CE 6674 | |
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| EC Certificate CE 597141 | ||
| Health Canada | Canada Establishment License | PDF Health Canada |
