Quality and Patent

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.

ISO13485

EXINI Diagnostics follow the rules and regulations of the European Medical Device Directive (MDD) 93/42/EEC. In order to be able to CE certify our products, we have implemented a quality management system which has led to a certification of the company according to the ISO 13485:2003 standard. This certification was made by the German TÜV in November 2006 and is repeated annually.


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CE marking

CE marking is a label for certification within the European Union. The marking is mandatory and must be affixed before a product can be sold on the European market. The CE marking states that the product meets the requirements imposed on the manufacturer and all European Union provisions.

EXINI Diagnostics’ products EXINI brain™ and EXINI heart™ both have CE marking.

FDA clearance

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.

The EXINI Diagnostics’ FDA clearance is pending. When this comes through, it opens up the American market for penetration according to the company’s plans.

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™.