Regulatory Information

Quality Policy

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:

  • Raise quality awareness among the employees by communicating quality objectives and encouraging employees to actively contribute to the QMS,
  • Maintain the effectiveness of the QMS to ensure that its processes and products comply with relevant quality standards and appropriate regulatory requirements,
  • Establish company-wide quality objectives based on this quality policy, and review them based on the information obtained from management reviews,
  • Perform internal audits and communicate quality standards and regulations to familiarize its employees with the framework and impact,
  • Continuously improve the software development process and the quality of software products,
  • Continuously improve products based on feedback from customers, medical specialists and technicians in hospitals or analysts in Core labs, and partners in Product Development or in supply and sales,
  • Provide adequate services to customers, partners and relations.

Applicable Standards

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:

  • EN ISO 14971:2012 ‘Medical devices – Application of risk management to medical devices’,
  • IEC 62304:2006/AC:2008 ‘Medical device software – Software life cycle processes’,
  • IEC 62366-1:2015 ‘Medical devices – part 1: Application of usability engineering to medical devices’,
  • EN ISO 15223-1:2016 (Cor. 2017-04) ‘Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements’,
  • EN 1041:2008+A1:2013 ‘Information supplied by the manufacturer of medical devices’.

Regulatory Approvals

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

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