At AcuteCare.Ai, regulatory compliance, data privacy, and operational excellence are fundamental pillars of our mission to deliver safe, secure, and innovative healthcare software solutions. We are fully committed to adhering to the highest standards, ensuring our systems support the needs of critical care environments while aligning with all applicable legal and regulatory frameworks.
EU Medical Device Regulation (MDR 2017/745)
Our solutions are developed and maintained in full compliance with the EU Medical Device Regulation (MDR), ensuring patient safety, clinical effectiveness, and regulatory transparency. As software intended for medical environments such as ICUs and Operating Rooms, we treat our products as medical devices and ensure full lifecycle conformity, from risk management to post-market surveillance.
General Data Protection Regulation (GDPR)
Data protection is central to our design philosophy. We follow Privacy by Design and by Default principles and ensure that all patient and hospital data handled by our systems are processed in strict accordance with the EU General Data Protection Regulation (GDPR). We implement encryption, access control, and anonymization methods, and maintain detailed data processing records.
Cybersecurity
We proactively aim to comply with the EU's updated cybersecurity directive, which imposes stricter obligations on essential service providers, including healthcare technology companies. Our infrastructure, risk assessment protocols, and incident response plans are designed to meet the Directive's enhanced security and reporting requirements.
Compliance with Greek National Legislation
Our compliance framework incorporates all relevant Greek national laws transposing EU directives, including:
- Law 4961/2022 (National Cybersecurity Strategy & NIS2 implementation)
- Law 4624/2019 (Greek adaptation of GDPR)
- Applicable provisions from ΕΟΦ and the Hellenic Ministry of Health concerning medical software and digital health records
Certified Excellence
Our commitment to quality and accountability is demonstrated through our certified management systems:
- ISO 9001:2015 – Quality Management System
- ISO 13485:2016 – Quality Management for Medical Devices
- ISO 27001:2022 – Information Security Management (coming soon)
- ISO 14001:2015 – Environmental Management System
- ISO 37001:2016 – Anti-Bribery Management System
Each certification is independently audited and regularly reviewed to ensure continuous improvement and alignment with international best practices.
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