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Abstrak :
ABSTRAK
Skripsi ini berisi bagaimana prosedur pengadaan alat kesehatan di rumah sakit berdasarkan peraturan perundang-undangan yang berlaku, ruang lingkup permasalahan hukum dalam kegiatan pengadaan alat kesehatan di rumah sakit serta analisis putusan No.06/Pid.Sus-TPK/2015/PN.Mam. Pembahasan dilakukan melalui analisis putusan No.06/Pid.Sus-TPK/2015/PN.Mam. Bentuk penelitian ini yuridis normatif dengan metode kualitatif. Hasil penelitian menyimpulkan Prosedur pengadan alat kesehatan di Rumah Sakit dibagi menjadi beberapa tahap. Tahapan tersebut dimulai dari perencanaan, persiapan pengadaan, pemilihan penyedia barang dan jasa hingga pelaksanaan kontrak. Pengadaan barang dan jasa dapat ditinjau dari 3 tiga aspek hukum yakni hukum perdata, hukum pidana dan hukum administrasi Negara. Dalam putusan 06/Pid.Sus/2015/PN.Mam, Dr H. Suparman sebagai Kuasa Pengguna Anggaran menjadi terpidana kasus tindak pidana korupsi karena tidak mengkoordinasikan, memantau dan mengevaluasi kegiatan pengadaan alat kesehatan di RSUD Provinsi Sulawesi Barat dengan baik, serta menerima uang suap dari Suwardi Koeshadhi sebesar Rp 50.000.000 Lima Puluh Juta Rupiah . Saran yang dapat diberikan untuk permasalahan tersebut adalah harus menegaskan pelaksanaan E-Procurement dengan panduan teknis dari peraturan perundang-undangan yang berlaku.

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ABSTRACT
This thesis discusses how the procurement procedures of medical devices in hospitals is based on legislation in force, the scope of the legal issues in the procurement of medical equipment in hospitals as well as analysis of the Verdict Number .06 Pid.Sus TPK 2015 PN.Mam. The discussion conducted through analysis of the Verdict Number Pid.Sus TPK 2015 PN.Mam . This research form is normative juridical qualitative methods. The study concluded the procurement procedures of medical equipment in the hospital is divided into several stages. The beginning stages of planning, preparation of procurement, the selection of providers of goods and services through the implementation of the contract. Procurement of goods and services can be viewed from three 3 the legal aspects of civil law, criminal law and the law of the State administration. In its Verduct number 06 Pid.Sus 2015 PN.Mam, Dr H. Supaman as a Budget Authority convicted of corruption because he did not coordinate, monitor and evaluate the activities of procurement of medical equipment in Province Hospital of West Sulawesi quiet well, and receive bribery money from Suwardi Koeshadhi up to Rp 50,000,000 Fifty Million Rupiahs . Advice can be given to these thessi are the need to the implementation of E Procurement with the technical guidance of the legislation in force.

Abstrak :
This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators.