Strategic Biocompatibility

A supplier swap or a small process adjustment can change a device's biological profile in ways no one planned for, and the result may be a delayed approval or a stalled launch. An integrated laboratory network covers material evaluation, long-term biostability, and the effects of sterilisation and aging. Its toxicologists, chemists, and biocompatibility specialists work through chemical characterisation, extractables and leachables, and toxicological risk assessment, with in silico methods such as QSAR and read-across used to flag hazards early.

Programmes are tailored to Class 1, 2, and 3 devices, combination products, and novel materials, for new submissions and post-market changes alike.

Explore the service scope to see which testing programmes fit your device.