Quality Management

Quality is our top priority. We have received a ISO 13485 certification, which highlights our dedication to the highest standards in medical software design and development. Our quality management system guarantees that ALINE meets the stringent quality standards throughout its entire life cycle. It addresses any potential risks or defects, implements a robust version management process, and ensures the traceability of materials and user-specific log recordings in compliance with the EU Tissue directive 2004/23/EC.

Patient safety

Patient safety stands as a central focus within ALINE’s design. ALINE’s tools have been engineered to preemptively prevent the occurrence of operational human errors.

Data security

ALINE has been developed with a strong focus on data security, ensuring compliance with the EU's General Data Protection Regulation (GDPR) requirements.

Legislation and guidelines

ALINE operates in accordance with the European Union (EU) Tissue Directive 2004/23/EC and ESHRE (European Society of Human Reproduction and Embryology) guidelines. We proactively monitor upcoming legislative changes, such as the EU's SoHo Directive. ALINE’s features can be customized to ensure compliance with local legislation.