EXAMION has already implemented a quality management system since 2004, which ensures compliance with the requirements of the ISO 13485 standard. As a certified company, we are a trusted partner for standard-compliant software and X-ray system development. We guarantee very high quality in the areas of human and veterinary medicine, in resident practices, clinics and hospitals, in- as well as outside of Europe.

ISO 13485 for medical device manufacturers

As a medical device manufacturer, EXAMION guarantees the highest level of transparency in all processes as well as internal and external processes. The feedback we gain from this, combined with our ambition to constantly develop, gives us the opportunity to continuously and effectively optimize quality as well as processes.

The effectiveness of our ISO 13485:2016-certified quality management system is regularly checked by our notified body DNV (www.dnv.com) as part of external audits. In addition, we also undergo internal audits in order to fully satisfy the high quality demands of our customers.

Certified quality of EXAMION products

EXAMION is a manufacturer of medical devices of risk classes I, IIa and IIb in accordance with the EU Medical Device Directive (MDD). Even after the Medical Device Regulation (MDR) came into force in May 2021, the MDD is still valid for our products. However, it is undisputable that the next certification of our products for digital X-ray will take place according to MDR.

IEC 62304 as a standard for our X-ray software

As a manufacturer of X-AQS X-ray software, we fully meet the requirements of the IEC 62304 standard in addition to the guidelines already mentioned. Among other things, this ensures that software development, maintenance, verification and validation are based on the best technical know-how for our customers and that the software life-cycle is fully monitored and optimized continuously.

Quality assurance and quality improvement

Our goal is to ensure patient safety with the quality of our products and to minimize the likelihood of “adverse events”. This is why risk management and product validation are our top priority. Thanks to these comprehensive activities, we offer maximum usability and safety and avoid human errors during application of your technical systems at the largest degree possible. Patient safety is paramount when using our digital X-ray systems.

Professionalism

We offer high-quality products as well as first-class service. EXAMION employees have excellent technical training and are available to answer all your questions with competence. Regular training and continuing education ensure that this know-how is constantly deepened and expanded.

Our quality policy and quality goals are comprehensively written and documented, which is why we can provide high-quality and safe development, production and services.

Continuous optimization of processes and procedures

In line with the high standards that we set for ourselves, and the strict requirements of EXAMION quality management, we strive to continuously optimize our processes and procedures. We put emphasis on establishing and maintaining communication within the company as well as with suppliers and customers in the best possible way. Our goal is to achieve better mutual understanding and ensure more efficient problem solving.

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