North America ISO Certifications
| Site | Standard | Notified Body | Certificate Number |
|---|---|---|---|
| Melville, NY | EN ISO 13485:2016 | MedCert | 7425GB445200327 |
| ISO 13485:2016 | Intertek | 9580-03 | |
| ISO 13285:2016 MDSAP | Intertek | 0085300-4 | |
| Denver, PA | ISO 13485:2016 MDSAP | Intertek | 0085288 |
| Sparks, NV | ISO 13485:2016 | Intertek | 9580-03 |
| Grapevine, TX | ISO 13485:2016 | Intertek | 9580-03 |
| Indianapolis, IN | ISO 13485:2016 | Intertek | 9580-03 |
| Jacksonville, FL | ISO 13485:2016 | Intertek | 9580-03 |
| Greenville, SC | ISO 9001:2015 | Intertek | 0020192-02 |