Quality assurance is at the centre of EXINI Diagnostics’ core business. The foundation of the company is the medical tradition of evidence-based research. Being a part of the health care sector also demands that the company upholds a high standard of quality in its products and services.
EU MARKETING AUTHORIZATION AND QUALITY
EXINI Diagnostics follow the requirements of the European Medical Device Directive (MDD) 93/42/EEC. In order to be able to affix the CE-marking on our products, we have implemented a full quality management system, which has led to certification according to the ISO 13485:2003 standard. This certification was made by the German Notified Body TÜV in November 2006 and is repeated annually. EXINI has also implemented in the quality management system the 21 CFR 820 QSR GMP (USA) and the CMDR (Canada).
By the declaration of conformity we ensure and declare that the products meet the requirements of the Directive.
EXINI Diagnostics’ products EXINI brain™, EXINI heart™, EXINI bone™ and EXINI dat™ bears the CE marking of conformity.
USA
The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating, among other things, medical products and devices, in the United States.
EXINI has filed a 510(k) notification.
When the clearance of the notification comes through, it will open up the American market for penetration according to the company’s plans.
OTHER COUNTRIES
EXINI products are approved for sales in Canada.
PATENT POLICY
EXINI Diagnostics follow a strategy to actively patent their products for diagnostic support.
To date, EXINI Diagnostics have a patent in Sweden for the image processing part of EXINI heart™ (# 0202753-0 “Procedure and device for determining a three-dimensional contour of an organ in a patient’s body”). The company also has a patent pending for its new product, EXINI brain™.
