ataloomX365 GmbH specializes in AI implementation, data protection, and regulatory compliance, focusing on healthcare, MedTech, and mid-sized businesses. We bring companies safely into AI adoption: GDPR-compliant, hosted with EU data sovereignty, and documented to audit standards.
Our three service areas:
AI & Digitalization: Deployment of AI solutions with EU data sovereignty, from strategy to operations. Process digitalization that holds up in daily practice.
Compliance & Data Protection: External data protection officers (TÜV-certified), GDPR documentation, NIS2, BSI C5, and MDR regulatory affairs for Software as a Medical Device (SaMD) and medical devices.
Cybersecurity: Security architecture, Microsoft 365 hardening, and IT security concepts for medical practices, outpatient centers, hospitals, and SMEs.
Our platforms:
AIRA (AI Risk & Compliance Assessment): The compliance platform for SaMD and medical devices. Digital compliance twin, regulatory foresight, and audit-ready MDR technical documentation via the Speed MDR Track. In days, not months.
NotPASS, the digital rescue chain: AI-native emergency and care platform, developed with partners from emergency medical services.
smart@work & smart@road: Digital workflows for occupational accident reporting, occupational medicine, and travel health.
StayLoomAI: AI-powered hospitality command center for hotels and events.
Data becomes care. Technology becomes routine. IT becomes trust.
Contact: dlx365.de | frank.nelles@dlx365.de
AI consulting, GDPR consulting, external data protection officer, MDR compliance, SaMD approval, IEC 62304, ISO 14971, BSI C5, NIS2, EU AI Act, healthcare IT security, medical device software, regulatory affairs

dataloomX365 GmbH

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dataloomX365 GmbH

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