Background  

Myelotec consistently complies with the requirements of various industry recognized quality managements systems and has successfully completed certification and re-certification. These essential requirements and principles of quality management systems are integrated into our standard daily operating processes and procedures. Myelotec is committed to providing its local and global customers with high quality products and services, and will continue to work with physicians, distributors and vendors to deliver quality that meets and exceeds expectations.

US FDA Quality System Requirements
ISO 13485 Certificate of Registration
Korean Good Manufacturing Practices Certification
EU Medical Device Directives 93/42/EEC
Australian Therapeutic Goods Amendment Essential Principles

 

  • EC Certificate
    Full Quality Assurance System
    Directive 93/42/EEC, Annex II
  • Certificate of Registration
    ISO13485:2003
  • FDA Registered Facility