Quality Certification and Regulatory Clearance

Resonance Health Analysis Services has a company-wide commitment to quality management and it is the responsibility of every employee, in every activity. Additionally, FerriScan^® is the first non-invasive technique for the measurement of liver iron concentration with regulatory clearance.

Our regulatory clearances, together with our quality commitment and certifications, provide our customers with the confidence they demand from a medical service.

All aspects of the provision of the FerriScan service are performed in accordance with our certified quality management system. From the recruitment and training of staff, to the receival of data and the quality control checking of results, documented procedures are followed and records retained. A primary focus of the company is the continual improvement of the quality management system and the service we provide, through monitoring and actioning of customer feedback, internal audits, and a corrective and preventative action system.

Our quality management system is certified to the following two international standards:

• ISO 9001: Quality Management Systems - Requirements; and
• ISO 13485: Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes.

In addition to these quality management system certifications, Resonance Health Analysis Services has regulatory clearance to market FerriScan in the following jurisdictions:

• Australia (Therapeutic Goods Administration);
• United States of America (Food and Drug Administration);
• Europe (CE Mark);
• Canada (Health Canada); and
• New Zealand (Medsafe).

The Resonance Health cardiac T2* analysis is delivered with the same rigorous application of quality control standards. It is available in Australia, New Zealand and the EU countries. It is available for trials in Canada and the USA with commercial approval expected late 2010.

FerriScan provides quality assured data acquisition  and analysis accredited to international quality standards ISO 9001 and ISO 13485