Iso 13485 2016 free download pdf

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Research, design, development and manufacturing including fermentation, purification, bio formulation, organic synthesis, dispensing, assembly, shipping of life science research products, including proteins, nucleic acids, nucleotides, master mixes, antibodies, bio-sample preparation and cell separation reagents and associated kits, for research and in-vitro diagnostics including processes under aseptic conditions. Manufacturing of nucleotides for in vitro diagnostics and further manufacturing.

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Design, development, and manufacturing of reagents, proteins, nucleic acids, nucleotides, antibodies, associated kits, and materials intended for ex-vivo separation of human cells for in vitro diagnostics, for further manufacturing and applied market applications, including processes under aseptic condition.

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