Itemedical develops advanced medical software solutions for critical care situations with patient safety as a priority. These solutions comply with legal requirements and guidelines as established in the MDR (Medical Device Regulation 2017/745). Itemedical has a certified Quality Management System (QMS) and conducts periodic audits to comply with this certification. This way you can be assured that our medical devices are patient-safe.
At itemedical we continuously strive for process improvement, including information security and compliance with international standards such as ISO/IEC 27001 and the Dutch NEN 7510 certification. You can trust that we take the protection of sensitive information and your patient data seriously.
Itemedical certification:
Continuous improvement
Itemedical performs Post-market surveillance (PMS) throughout the entire lifecycle of its medical software, including Post Market Clinical Follow-up (PMCF). We periodically analyze clinical data to test whether the software meets current safety and performance requirements. We record the conclusions in a Periodic Safety Update Report (PSUR), which provides insight into use, risks and clinical results. This leads to continuous improvements, such as better configuration of our MediScore Medical Device Data Gateway (MDDG) with fewer unnecessary alarms and a faster response.
You can find our registration as a manufacturer and distributor of medical devices in EUDAMED (European Databank on Medical Devices) via:
- SRN number: NL-MF-000010918 (Manufacturer)
- SRN number NL-IM-000012580 (Distributor)