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Quality management

At Arseus Medical Group we attach great importance to quality. Our goal is to fully meet the needs and expectations of our customers at every opportunity. Our team plays a vital role in achieving this goal. 

It is our pride to maintain the highest level of service and quality at the best value for money. 

Our promise is to provide reliable and effective products and high quality service, in a friendly, efficient and well-maintained environment, with respect for sustainable solutions. 

We undertake to comply with all applicable regulations. Quality is a continuous process in which the internal and external feedback information forms a basis for improving the effectiveness of our quality management system. 

We achieve quality by meeting our own standards, through defined objectives and procedures. 

Whether we meet the quality standard and we are convinced that our stakeholders will give an affirmative answer, are questions that we ask ourselves every day.

ISO 9001:2015 certification

The quality management system of the Arseus Medical group is based on the International Quality Standard ISO 9001:2015 and is applicable to the distribution, warehousing, sales and servicing of medical devices.

In order to provide high quality products and services, the Arseus Medical group works with a quality management system that meets the requirements of the European Regulation (MDR 2017/745 and IVDR 2017/746) and the guidelines mentioned in the Belgian Royal Decrees of 18 March 1999 (MDD 93/42/EC) and 14 November 2001 (IVD 98/79/EC).

The Arseus Medical group provides medical devices and services for cardiology, pneumology, gynecology, vascular surgery, orthopedic surgery, physical rehabilitation, physiotherapy, patient mobility, ophthalmology, optometry, intensive care, operating room, emergency, general practitioners, equipment and reagents for in vitro diagnostics, equipment and patient care solutions for residential care centers. 

The quality management system and ISO 9001:2015 certificate no. 0108550 apply to all companies below.

  • Arseus Medical NV (BE 0435.200.792), Rijksweg 10, 2880 Bornem, Belgium 
  • Arseus Hospital NV (BE 0440.200.450), Rijksweg 10, 2880 Bornem, Belgium 
  • DMB Medical NV (BE 0822.887.226), Rijksweg 10, 2880 Bornem,Belgium
  • eXmedical BV (BE 0471.466.025), Rijksweg 10, 2880 Bornem, Belgium 
  • Van Hopplynus Ophtalm NV (BE 0447.467.334), Rijksweg 10, 2880 Bornem, Belgium 
  • Arseus Medical BV (NL 854141194B01), Cartografenweg 18, 5141 MT Waalwijk, The Netherlands

ISO 13485:2016 certification
Since 2016, the quality management system of BlooMEDical Benelux BV has been based on the international quality standard ISO 13485:2016 and relates to the distribution of non-active implantable devices (like breast implants, facial implants and surgical scaffolds) and the distribution of active non-implantable devices for skin care (like lasers and LED based therapeutic devices with medical purpose).
Approval number(s): ISO 13485 – 00019687
Heart Medical Europe BV has been certified ISO 13485:2016 since 2021. The certification has been assessed under the management system of the certified organisation defined in the main certificate BE20/819944143 and is applicable to the storage, installation and distribution of sterile and non-sterile non-active non-implantable and implantable medical devices for the area of interventional (pediatric) cardiology, interventional radiology and cardio thoracic surgery and for the storage distribution and installation of in vitro diagnostic medical devices.

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