Terry dalam bukunya The Principle of Management, manajemen ialah usaha-usaha yang dilakukan untuk mencapai tujuan yang sudah ditetapkan lebih dahulu dengan menggunakan kegiatan orang lain.Yuk, langsung saja simak pembahasannya satu per satu lebih detail di bawah ini.Pelaksanaan merupakan fungsi manajemen yang paling penting karena berhubungan dengan sumber daya manusia.
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This is how one can understand the central difference between them: the Design History File (along with Design Control), is the most important among the regulatory documents that the FDA requires for medical devices, while the Technical File and Design Dossier are documents that serve the same purpose, however, within the EUs regulatory body, the Medical Device Directive (MDD).These documents constitute core regulatory requirements within these regulatory bodies.At a basic level, the major similarity between them is their intended purpose, while what they should contain is the main difference between the two.The Design Control and the Design History File (DHF) are mandated by the FDAs CGMPs in 21 CFR 820.30, while for the EU; the core requirement is its CE-marking documentation the Technical File or Design Dossier, as described in the MDD.
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