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Laboratory technician reviewing test data on a computer beside advanced diagnostic analyzers in a modern clinical lab.

Trust at every step of
the diagnostic journey

In diagnostics, trust is essential.

Ascentry delivers digital solutions developed and operated within certified quality and security management systems, with a strong focus on regulatory accuracy, data protection, and operational reliability.

Our approach covers information security, quality management, and controlled software lifecycle practices to support safe, resilient, and audit‑ready laboratory operations.

A foundation built on security, quality, and reliability

Ascentry develops software solutions for demanding diagnostic environments.

We build platforms that are designed to protect sensitive diagnostic data, support regulatory compliance, and operate reliably across clinical and laboratory workflows.

Our compliance posture is based on certified management systems held by specific legal entities within the Ascentry Group, and on disciplined engineering and operational practices.

 

ISO/IEC 27001:2022

Information security management system

Security is at the heart of our software development and customer services, globally. Our products are secure by design, ensuring data protection, risk management, and lab operations continuity across all teams and partners.

All employees, contractors, and collaborators foster a culture of vigilance, confidentiality, and continuous protection. As digital threats evolve, we ensure your operations remain safe, compliant, and resilient.

Ascentry Finland operates an ISO/IEC 27001:2022 certified Information Security Management System (ISMS). Validation Manager is developed and operated under this certified information-security management system.

Certification applies to the management system of Ascentry Finland (Finbiosoft Oy).

Why ISO/IEC 27001:2022 matters

ISO/IEC 27001:2022 is an internationally recognized standard for information security management. Aligning our Information Security Management System (ISMS) with this standard ensures that we consistently establish, maintain, and improve the processes that protect your data and secure your diagnostic workflows.

External audits and continuous validation

Our ISMS is strengthened through multiple layers of independent verification. Rigorous third-party audits by accredited certification bodies validate our ISO/IEC 27001:2022 compliance, while regular penetration testing by independent security experts verifies our technical security controls remain effective against real-world threats.

ISO 13485:2016

Quality management system for medical device software

Quality is at the heart of our software development and customer services, worldwide. Our products are designed and developed with quality by design principles, ensuring regulatory compliance, risk management, and continuity of laboratory operations across all teams and partners.

All employees, contractors, and collaborators foster a culture of quality, accountability, and continuous improvement. As regulatory and industry requirements evolve, we ensure your operations remain compliant, reliable, and resilient.

Ascentry France (BYG Informatique SAS) operates a Quality Management System (QMS) certified to ISO 13485:2016, the international gold standard for organizations involved in the design, development, and maintenance of medical device software.

Lab Composer, POC Controller, Infection Tracker, and related solutions are developed by Ascentry France under this ISO 13485:2016 certified quality management system. These products are delivered under controlled, traceable, and auditable processes throughout the entire product lifecycle.

Certification applies to the management system of Ascentry France. Products themselves are not certified.

What ISO 13485:2016 ensures

  • 1

    Regulatory-compliant software development

    based on defined, controlled, and validated lifecycle processes in line with applicable regulatory requirements

  • 2

    End-to-end traceability

    from user and system requirements through design, verification, validation, release, and maintenance activities

  • 3

    Lifecycle risk management

    applying risk-based approaches aligned with patient safety principles and clinical use, in accordance with recognized standards

  • 4

    Planned and consistent quality controls

    integrated at every stage of development, including reviews, verification, and validation activities

  • 5

    Robust documentation and audit readiness

    ensuring traceable, controlled records to support notified bodies, partners, and customers

Have questions?

Please contact us to get help with your questions regarding the safety and security of our products and operations.