Safety, quality and regulatory compliance in every clinical data
Information security, protection of clinical data and process quality are fundamental pillars of Better Care’s strategy. Our technological solutions are developed and operated under stringent international standards, with regular audits conducted by independent entities.
National Security Scheme (ENS — Spain)
Better Care’s solutions comply with the high-level security requirements defined by the ENS, ensuring the confidentiality, integrity, traceability and availability of healthcare information across both public and private environments.
Download ENS certificate
ISO/IEC 27001 — Information Security Management
The ISO/IEC 27001 certification confirms that Better Care has implemented and maintains a robust and continuously improving Information Security Management System (ISMS).
Download ISO/IEC 27001 certificate
ISO/IEC 27701 — Information Privacy Management
ISO/IEC 27701 extends the security framework by incorporating privacy and personal data protection management, particularly relevant in the healthcare sector.
Download ISO/IEC 27701 certificate
ISO/IEC 13485 — Quality Management System for Medical Devices
The ISO 13485 certification demonstrates that Better Care operates a Quality Management System specifically designed for medical devices, aligned with international regulatory requirements.
Download ISO/IEC 13485 certificate
MDSAP — Medical Device Single Audit Program
MDSAP enables a single audit to be recognised by multiple international regulatory authorities (including the United States, Canada, Australia, Japan and Brazil).
Download MDSAP certificate
CE seal — European Community
The CE marking certifies that BC Link® complies with essential safety, performance and conformity requirements established by applicable European medical device regulations.
Health Canada License
Compliance with Health Canada certifies that BC Link® meets Canadian regulatory requirements in terms of safety, effectiveness and quality for medical devices.
Download Health Canada certificate