Certificates and compliance with international standards
Advanced Medical Diagnostics is committed to optimum patient care and operator, patient safety and international regulation and standards.
Quality Management System (QMS)
Advanced Medical Diagnostics QMS is certified to ISO 13485 and CAN/CSA ISO 13485
- ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
- Certificates numbers 2120119 and 2129333 issued by DEKRA Certification BV.
Regional approvals
In the European Union (EU)
- HistoScanning™ is CE Marked under the European Medical Device Directive (MDD) 93/42/EEC as amended by 2007/47/EC Annex II.
- Certificate number 2115828CE01 (2115828CN) issued by DEKRA Certification BV).
In Canada (CDN)
- HistoScanning™ is licensed by Health Canada since 2009.
- Certificate number 81234 issued by Health Canada – Santé Canada (CDN).
Pending regional approvals
In the United States America (USA)
- HistoScanning™ is currently not yet available for commercial use in the United States of America.
For any question, please feel free to contact our Regulatory Affairs and Quality Assurance Manager at: 
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.Last modified: 15 Dec. 2011