We are proud to have received the MDSAP (Medical Device Single Audit Program) certification again this year. This confirms our commitment to the highest international standards in the development of our medical software.

MDSAP was created by the International Medical Device Regulators Forum (IMDRF), an association of international authorities and legislators, and is currently recognized in five countries:

• Australia – Therapeutic Goods Administration (TGA)
• Brazil – Agência Nacional de Vigilância Sanitária (ANVISA)
• Canada – Health Canada (HC)
• Japan – Pharmaceuticals and Medical Devices Agency (MHLW)
• USA – S. Food and Drug Administration (FDA)

This comprehensive audit thoroughly examines our processes and systems and guarantees that we comply with globally recognized quality and safety standards. It has been confirmed that our system fulfils the requirements of the following standard ISO 13485 : 2016

Through MDSAP certification, we can further ensure that our products meet the strict regulatory requirements of these countries. This gives our customers and partners the confidence that they can rely on the reliability and safety of our medical software.

We would like to thank our dedicated team for their continuous work and commitment that has made this success possible. We will continue to strive to maintain excellent quality standards and exceed our customers’ expectations.

We are pleased to present the MDSAP certification to you.

An overview of all certifications can be found here.

Mr. H. Aro, Quality Manager, proudly presents the
awarded certificate.