Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Critical issues

Sterility and pyrogenicity Biocompatibility – ISO 10993-1 Compatibility of device with the cells ● Samples passed through system compared to a reference sample – Cell viability – Cell count – Potency – Incucyte – growth on recovery imaging Accuracy and precision No Human Factors testing required by FDA ● Justified as no critical tasks

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Example 2 – Nerve repair

Peripheral nerve repair – reconnecting severed nerves ● Main causes: accidents, fractures, lacerations, wounding, surgery, compression syndromes

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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