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| Signifix is focussed on innovative biomedical, biotechnology & human tissue engineered medical product technologies, advanced therapy medicinal products, medical devices, animal tissue devices and combination/borderline medical products. | Our range of consultancy services covers developing and implementing quality & regulatory strategies, setting up quality systems, managing regulatory approvals (including 510K, PMA, IDE, IND, BLA and CE mark), managing quality system certification processes, providing advice & support in all phases of product development, performance of auditing (internal/vendor), training/coaching and problem solving. |  |