Regulatory Information

Quality Policy

Medis’ products support medical professionals with clinical decision making tasks and the interpretation of clinical research studies by providing quantitative tools. 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;
  • Establish company-wide quality objectives based on this quality policy, and review them based on the information obtained from management reviews of the QMS;
  • Perform internal audits and communicate quality standards and regulations to familiarize its employees with the framework and impact;
  • Enhance the software development process and the quality of software products by implementing level 2 or higher of the Capability Maturity Model Integration (CMMi®) for software development;
  • 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.

Regulatory Approvals

Medis Medical Imaging Systems bv has established and maintains a Quality Management System (QMS) to comply with European Medical Device Directive 93/42/EEC. Therefore, the company holds the recognized ISO 13485:2016 and MDSAP (ISO 13485:2016) certifications from SGS, UK.

In addition, Medis has obtained US FDA 510(k) market clearance letters for most of its products, as well as PMDA approval. Further, Medis has obtained KFDA approval by fulfilling the Korea Good Manufacturing Practice (KGMP) for most of its products.

Medis’ software development process conforms to IEC 62304:2006/Amd 1:2015 “Medical device software – Software life cycle processes” and IEC 62366-1:2015 ”Medical devices – part 1: Application of usability engineering to medical devices”. Further, a risk management process is followed, based on ISO 14971:2012 “Medical device software risk management” to identify potential risks and mitigate these risks as a part of the product life cycle.

B. Goedhart, Ph.D.
Vice President R&D
Regulatory Affairs and Quality Assurance representative
Email: bgoedhart@medis.nl
Phone: +31 71 5241 700