Since 2004, EXAMION has had a quality management system in place that ensures compliance with the requirements of the ISO standard 13485. As a certified company, we are a trusted partner for standard-compliant software and X-ray system development. We are able to guarantee the highest quality standards for our products and services for use in the areas of human and veterinary medicine, independent private practices, clinics and hospitals, in and outside 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, together with our focus on ongoing development for our products and services, gives us the opportunity to continuously and effectively optimise quality and improve procedures.
The effectiveness of our ISO 13485:2016-certified quality management system is regularly verified by our reporting body DNV (link: 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 in 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, the next formal certification of our digital X-ray products will be undertaken in accordance with the 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 continuously subject to further optimisation.
Quality assurance and quality improvement
Our goal is to ensure patient safety through the quality of our products and to minimise any possibility 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.
We offer high-quality products as well as first-class service. EXAMION employees have exceptional technical training and are fully qualified to respond to all your questions with confidence. Regular training and continuing education ensure that this technical knowledge base is constantly expanding.
Since our quality policy and quality objectives are explicitly formulated and documented, and we are thus able to provide the appropriate high-quality and safe development, production, and service facilities.
Continuous optimisation of processes and procedures
In line with the high standards that we set for ourselves, and the strict requirements of the EXAMION quality management system, we continuously strive to optimise our processes and procedures. We put substantial emphasis on establishing and maintaining good communication within the company as well as with suppliers and customers in the most effective way possible. Our goal is always to achieve mutual understanding and ensure the most effective and prompt resolution of any problems that may arise.