Quality & Certificates
Every instrument is built inside a certified quality system.
ISO 13485
Quality management system for medical devices — design, production and traceability.
ISO 9001
Internationally recognised quality management across our whole organisation.
CE Mark
Conformity for sale in the European Economic Area, per council directive 93/42/EEC.
C-GMP & US FDA guidelines
Manufacturing practices aligned with current Good Manufacturing Practice and US FDA guidance.
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Contact us for copies for your tender, registration or distributor files.
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