Home Compliance and certifications

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 non-negotiable. Ascentry delivers reliable, secure, and compliant digital solutions backed by certified quality processes, robust engineering, and strict regulatory alignment. From data protection to software lifecycle management, we ensure your operations are safe, resilient, and audit-ready.

A foundation built on security, quality and reliability

Every product we deliver, from middleware to advanced workflow orchestration, is engineered to meet the demands of modern diagnostics. We build platforms that protect sensitive diagnostic data, support regulatory compliance, and perform reliably in demanding clinical environments.

ISO/IEC 27001

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.
The design, development, maintenance, support, of our cloud-hosted product – Validation Manager – operate an ISO/IEC 27001 certified management system.

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.

Why ISO/IEC 27001 Matters

ISO/IEC 27001 provides a comprehensive, internationally recognized approach to information security. 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 & Continuous Validation

Our ISMS is strengthened through regular audits performed by independent accredited bodies. These external reviews verify that our security practices remain aligned with global standards — ensuring top-level security wherever we operate.

ISO 13485:2016

Certified 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.

Our organization operates a certified Quality Management System (QMS) compliant with ISO 13485:2016, the international gold standard for organizations involved in the design, development, and maintenance of medical device software.
The design, development, maintenance, and support of lab products, Lab Composer, POC controller, Infection Tracker and derivates, are performed under controlled, traceable, and auditable processes throughout the entire product lifecycle.

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.

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.