Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Design and construction

NSC differentiate and self-align in medical grade acid extracted bovine collagen rectangular mould

Rolled into a 15mm cylinder

Cylinders wrapped in outer collagen tube (approved medical device) of tensile strength similar to human nerve

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How is this product regulated in Europe?

A. Medical Device? B. Combined ATMP? C. Somatic cell therapy? D. Tissue engineering product?

TOPRA MSc Module 18: Drug Device Combinations and other Technology

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