Diasoft B.V.

Diasoft B.V. specializes in cloud-based medical record solutions for renal dialysis. Their primary offering is the Diamant system, a specialized renal medical record solution designed for global use in dialysis care. Additionally, they provide a Device- & Systems Integration Engine and a Dialysis Medical Record Solution as part of their SaaS (Software-as-a-Service) platform. These solutions are built to minimize on-premise infrastructure needs while ensuring compatibility with existing dialysis systems.

Diasoft B.V. is headquartered in the Netherlands. While the company’s exact international presence isn’t detailed, its cloud-based solutions are hosted through ISO27001-certified partners in regions including the EU, UK, Canada, and Australia. This global infrastructure supports its SaaS offerings, allowing healthcare providers worldwide to access its renal dialysis record systems.

Diasoft B.V.’s devices, including the Diamant system, fall under EU Class IIb classification. This classification is determined based on the risk associated with the device’s intended use in renal dialysis care. Class IIb devices require stricter regulatory oversight than lower-risk classes but are not considered the highest risk (Class III). The classification ensures compliance with the Medical Device Regulation (MDR) in the EU.

Yes, Diasoft B.V.’s devices are registered in the eudamed database. eudamed is the EU’s official registry for medical devices, where manufacturers must list their products to comply with MDR (Medical Device Regulation) requirements. This registration ensures transparency and traceability of devices marketed within the European Economic Area (EEA). The company’s inclusion in eudamed confirms its devices meet EU regulatory standards.

Diasoft B.V.’s devices are governed by the Medical Device Regulation (MDR) in the EU and the Medical Device Single Audit Program (MDSAP). MDR is the current EU-wide framework ensuring high safety, performance, and traceability standards for medical devices. MDSAP is an international audit program that allows regulatory authorities to recognize each other’s audits, streamlining compliance for manufacturers operating in multiple jurisdictions. Both frameworks ensure rigorous oversight of the company’s cloud-based renal dialysis solutions.