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Prevas ISO 13485 certified -

quality management system standard for medical devices

Prevas was the first IT consultancy firm in Sweden to become ISO 9001 certified, and the company is now certified according to the ISO 13485 standard as well. Prevas also adheres to the IEC 62304 standard for software development for medical devices.
 
ISO 13485 is a standard for developers and manufacturers of medical devices, and it is frequently used as the framework for quality management systems in terms of ensuring adherence to the regulatory requirements for medical devices (such as CE marking) in various markets.
 
Prevas' customers are found all over the world. To help our customers compete in the global market, Prevas has established several Centers of Excellence (CoE); the Life Science center in Stockholm/Solna is one example. Prevas provides specialists, project teams with specific domain expertise and technical platforms in order to develop profitable turnkey solutions. As a means of further helping our customers in the medical device industry, Prevas' CoE Life Science is now certified according to ISO 13485:2003.
 
"The ISO 13485 certification is clear confirmation to us that the development services we supply correspond to the stringent quality demands placed on medical devices. The certification distinguishes us from other suppliers and satisfies our customers' demands," says Thomas Schaumann Regional Manager for Prevas in Stockholm/Solna.
 
Prevas is a Nordic leader in complex development projects for medical devices, biotechnology and in vitro diagnosis. Prevas' expertise and extensive experience within product development has resulted in many innovative and award-winning products for our customers.
 
For more information contact Prevas: info@prevas.dk

 
About Prevas
Prevas was founded in 1985 and is currently the Nordic leader for embedded systems and industrial IT. We are the main supplier and innovative development partner to leading companies in industries such as life science, telecommunications, vehicle, defense, energy and engineering. Prevas' core operation is to develop intelligence in products and industrial systems for world-leading companies. Prevas´ solutions are renowned for innovation, quality assurance and reliable delivery. Offices are located in Sweden, Denmark, Norway, the United Arab Emirates and India. The company has just over 500 employees. Prevas has been listed on the NASDAQ OMX Nordic Exchange in Stockholm since 1998.

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info@prevas.dk

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