Diamant Quality Summary
Diamant Medical Device
Diamant is a CE marked medical device, a software package to be used in hospitals and dialysis centres for the complete coverage of all aspects of the dialysis patient treatment.
According to the European legislation (MDD 93/42/EEC, MDR EU 2017/745) stand-alone software with a medical purpose should be classified according to the rules.
These classification rules are based on the vulnerability of the human body and take into account the potential risks associated with the technical design and manufacture of the devices.
To guarantee the highest level of safety for the patient and the user, the software Diamant is classified as a class II b device. Because the information in the software will be used to take medical decisions, which have an impact on the patient’s state of health.
All Diamant functionality and all new developments in the application have been thoroughly assessed on foreseen hazards and possible risks. These risks are reduced to the lowest possible level. This guarantees the highest level of Patient Safety.
The design takes into account reliability, performance, ease of use and years of experience, including customer feedback (Post Market Information). The medical device is extensively tested and validated before market-release.
In Diamant sensitive patient data is protected against unauthorized access by means of security profiles, so that the data is managed and controlled in a secure way.
Diasoft as an organisation takes the responsibility during the total life cycle of the medical device for continuous improvement in a systematic approach.
Quality Management system
A certified management system gives our organisation a framework for good management practice that we apply in our processes.
Diasoft has a certified Quality Management System compliant with ISO 13485:2016 and ISO 9001:2015 and an integrated Information Security Management System conform ISO 27001:2013 .
Diasoft takes utmost care to keep compliance with all the applicable national and international standards and regulations in a pro-active way. Not just because we want to comply with the rules, but because we believe this will improve our products, our processes, customer satisfaction and decision-making.