Quality Management

Quality is our top priority. We have received an 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 and ensures a robust version management process.

Compliance

ALINE has been certified as an A1 category Patient Information System by Valvira, the National Supervisory Authority for Welfare and Health in Finland. It holds a cybersecurity certificate granted by Nixu Certification Oy (now DNV), confirming that it meets the data security requirements set by the Finnish Institute for Health and Welfare (THL) regulation on the essential requirements for social and healthcare information systems (5/2021).

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.

Server Safety

ALINE's cloud service provider is ISO 27001-certified, confirming that it complies with the strictest requirements for security and data protection.

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.

Legislation and Guidelines

ALINE operates in accordance with the European Union (EU) Tissue Directive 2004/23/EC. It ensures the traceability of gametes, materials, and user-specific log recordings.

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.

We adhere to ESHRE (European Society of Human Reproduction and Embryology) guidelines.