Quality and Regulatory Information

Quality Policy

“Quality is our top priority, because our end customers, the healthcare professionals, are entitled to best-in-class cardiovascular software solutions on which the well-being of their patients depends.”  We design, develop, manufacture, distribute, install and support high quality, customer-centric and outcome-driven software solutions for cardiovascular imaging that are safe, accurate, useable and effective and meet all relevant quality standards and applicable regulatory requirements.  We ensure the effectiveness of our Quality Management System through a cultivated mindset that embraces setting and deploying (quality) objectives, problem-solving and leadership as the keys to continuous and sustainable improvement and development of our employees’ capabilities, our products and processes.  Medis Medical Imaging Systems bv has established a comprehensive Quality Management System specifically intended for the design, development, manufacture, distribution, installation and servicing of medical software solutions for cardiovascular imaging that is certified to guarantee compliance with applicable global quality systems standards and regulations.   

Applicable Standards

Medis Medical Imaging Systems bv has established and maintains a Quality Management System which is certified under EN ISO 13485:2016: “Medical devices – Quality management systems – Requirements for regulatory purposes”. 

Regulatory Compliance

Medis declares that its products meet the relevant provisions of Annex I ‘Essential Requirements’ of the European Medical Device Directive 93/42/EEC including the revision 2007/47/EC and Annex I ‘General Safety and Performance Requirements’ of the European Medical Devices Regulation 2017/745.   In addition, for its clinical use products, Medis has obtained US FDA 510(k) market clearance letters, is registered with Health Canada and holds a Canadian license, are in accordance with the requirements of the Australian Therapeutic Goods Regulations and have obtained Japanese PMDA and South-Korean MFDS approval.   

Contact information

If you have any questions to Medis Medical Imaging Systems bv concerning quality assurance or regulatory affairs or want to receive a copy of one of our certificates, please contact us: qara@medisimaging.com