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Myelotec continually strives to provide our customers with innovative, minimally invasive, quality products that provide quality of life resolutions for their patients.
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| Standard | Status |
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EC Certificate
Full Quality Assurance System
Directive 93/42/EEC, Annex II |
Examination by authorities determined that Myelotec’s quality assurance system conforms with relevant provisions of Directive 93/42/EEC and the Swedish national legislation. Myelotec, Inc. is thereby entitled to use the CE marking on products listed. |
Certificate of Registration
ISO13485:2003 | Myelotec’s Quality Management System has been assessed and registered by Intertek Testing Services NA Ltd and found to be in conformance to the requirements of ISO13485:2003. |
| FDA Registered Facility
| Myelotec’s facility is registered with the FDA and its products are listed in the FDA database. |
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