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The intelligent approach to biological safety

We perform tests, characterizations and evaluations of the biological safety of your medical devices and manufacturing processes

using intelligent strategies instead of cost-intensive “cookie-cutter” testing programms
as product-specific processes, considering all available material, product and process information
supported with valid, high-sensitive and high-informative test systems
in compliance with up-to-date directives, standards and guidance documents
drawing on expertise that extends far beyond mere implementation of guidance documents and normative specifications
to establish optimized product and patient safety

Qualification of biocompatibility of devices/materials
Qualification and monitoring of manufacturing, cleaning, packaging and sterilization procedures and packaging systems
Validation of reusability