Quality & Regulatory Downloads and 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 | 1833117 | Search FDA |
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International Certifications
| Europe EC Certificates | EC Certificate CE 66745 | |
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| EC Certificate CE 597141 | ||
| Health Canada | Quality Sys. Cert. MD560630 | PDF Health Canada |
Social Media Policy
| Social Media Policy | Reference Document |
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