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Quality Standards

Quality is necessary!

We meet the highest standards and we are only happy when our customers are too. That is why we are willing to keep learning and keep improving.

To us, quality is systematic!

We use pioneering methods and techniques such as risk management, failure mode and effects analysis (FMEA), fault tree analysis (FTA) and ongoing technical audits and customer reviews to make our products among the very best on the market.

 
 
 
 
 
 
 
 
 
 
 
 
 

I.E.M. means certified safety!

Our products and services are developed in accordance with international standards and undergo extensive testing in line with specific and relevant standards:  in-house, by independent test institutions and under the critical eye of internationally renowned clinics and clinical research organisations.

Our software and system development process accompanies the product development process from the request for the medical product through to clinical testing. Together with our customers, we develop efficient and innovative solutions and integrate requirements in accordance with IEC 62304, DIN EN 60601-1-4 and ISO 12207.

We incorporate quality requirements (e.g. as per ISO/IEC9126) as a natural part of the development process from the outset. We define adapted quality management approaches (e.g. in compliance with ISO 13485) as supporting processes and use them as a systematic means of implementing optimum customer and patient satisfaction within the equipment technology or service.