Medis’ products support medical professionals with clinical decision making and interpreting studies. Medis defines the following policy. For this, Medis has a Quality Management System (QMS) in place in which Medis has defined the following quality policy:
Medis Medical Imaging Systems bv has established and maintains a Quality Management System which is subject to EN ISO 13485:2016: “Medical devices – Quality management systems – Requirements for regulatory purposes”, for which Medis has obtained both UKAS and MDSAP certifications from SGS, UK.
Further, Medis’ products are developed in conformity with the following standards related to medical devices:
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. The Medis CE certificate is issued by SGS Belgium under number 1639.
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 2002 and have obtained PMDA and KFDA approval.
For further information please contact:
Bob Goedhart, Ph.D.
Head of Quality Assurance and Regulatory Affairs
Email: bgoedhart@medisimaging.com
©2022 Medis Medical Imaging Systems B.V. All rights reserved. Last updated: 06-12-2022