Trust & Compliance: how our products are built, secured and operated
Our products are used in research, clinical trials and routine pathology. Every product is developed under our ISO 13485 quality management system and protected by an ISO 27001 certified security program.
ISO 13485 certified
Quality management
ISO 27001 certified
Information security management
GDPR
EU data protection
Quality Management
ISO 13485 certified, applied to every product
Our quality management system is certified to ISO 13485, the international standard for medical device quality management.
The same processes apply to all our products, whether or not they are medical devices.
Design control framework
Medical software development
Software developed to IEC 62304.
Risk
management
Risk managed across the lifecycle to ISO 14971.
End-to-end
traceability
Requirements traced through to verification and validation.
ISO 27001 certified information security
Our information security management system is certified to ISO 27001, with a risk-based approach to protecting data through documented controls, regular audits and continuous improvement.
Control areas
Organizational
controls
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People
controls
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Technological
controls
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Physical
controls
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Frequently asked questions
What does ISO 27001 certification cover?
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How is certification maintained?
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How do I contact your Data Protection Officer?
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How do I report a security issue?
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