Pharmaceutical systems
We implement and test your critical software.
Software compliance
We have long experince with ensuring compliance to software development standards (such as IEC 62304 and GAMP 5), cybersecurity guidelines, data protection legislation and other regulation and best practices.
For most efficient collaboration, involve us early to help with strategy and compliance plan.
Software testing
We help create and implement the test strategy for your critical software to ensure it covers relevant areas such as functional, performance, security, usability whilst ensuring highest level of document compliance.
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Success stories
Pharmaceutical Serialisation
The falsification directive (FMD) was issued in 2011 and came into force on 9 Feb 2019 to ensure that all prescription medicines sold in Europe are verified to be authentic prior to being sold. The system is a pan-European IT system that affects all involved in the pharmaceutical industry.
Malsen Medical has been working on this project from around 2015 in various roles. We worked both in testing the system globally prior to launch and building up the QMS systems locally in several countries and fostering pan-European collaboration. We continue to support and develop the system further in Europe and now also in Africa.
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