Objective: Medical device development, from the product's conception to release to market, is very complex and relies significantly on the application of exact processes. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies, discuss its phases, and evaluate the associated legislative and risk aspects. Methods: The literature search was conducted to detect peer-reviewed studies in Scopus, Web of Science, and Science Direct, on content published between 2007 and November 2019. Based on exclusion and inclusion criteria, 13 papers were included in the first session and 11 were included in the second session. Thus, a total of 24 papers were analyzed. Most of the publications originated in the United States (7 out of 24). Results: The medical device development process comprises one to seven stages. Six studies also contain a model of the medical device development process for all stages or for just some of the stages. These studies specifically describe the concept stage during which all uncertainties, such as the clinical need definition, customer requirements/needs, finances, reimbursement strategy, team selection, and legal aspects, must be considered. Conclusion: The crucial factor in healthcare safety is the stability of factors over a long production time. Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. The key issues that must be addressed in the future are the consistency in the classification of devices throughout the EU and globally, and the transparency of approval processes.
Botnet is a significant cyber threat that continues to evolve. Botmasters continue to improve the security framework strategy for botnets to go undetected. Newer botnet source code runs attack detection every second, and each attack demonstrates the difficulty and robustness of monitoring the botnet. In the conventional network botnet detection model that uses signature-analysis, the patterns of a botnet concealment strategy such as encryption & polymorphic and the shift in structure from centralized to decentralized peer-to-peer structure, generate challenges. Behavior analysis seems to be a promising approach for solving these problems because it does not rely on analyzing the network traffic payload. Other than that, to predict novel types of botnet, a detection model should be developed. This study focuses on using flow-based behavior analysis to detect novel botnets, necessary due to the difficulties of detecting existing patterns in a botnet that continues to modify the signature in concealment strategy. This study also recommends introducing Independent Component Analysis (ICA) and data pre-processing standardization to increase data quality before classification. With and without ICA implementation, we compared the percentage of significant features. Through the experiment, we found that the results produced from ICA show significant improvements. The highest F-score was 83% for Neris bot. The average F-score for a novel botnet sample was 74%. Through the feature importance test, the feature importance increased from 22% to 27%, and the training model false positive rate also decreased from 1.8% to 1.7%. ABSTRAK: Botnet merupakan ancaman siber yang sentiasa berevolusi. Pemilik bot sentiasa memperbaharui strategi keselamatan bagi botnet agar tidak dapat dikesan. Setiap saat, kod-kod sumber baru botnet telah dikesan dan setiap serangan dilihat menunjukkan tahap kesukaran dan ketahanan dalam mengesan bot. Model pengesanan rangkaian botnet konvensional telah menggunakan analisis berdasarkan tanda pengenalan bagi mengatasi halangan besar dalam mengesan corak botnet tersembunyi seperti teknik penyulitan dan teknik polimorfik. Masalah ini lebih bertumpu pada perubahan struktur berpusat kepada struktur bukan berpusat seperti rangkaian rakan ke rakan (P2P). Analisis tingkah laku ini seperti sesuai bagi menyelesaikan masalah-masalah tersebut kerana ianya tidak bergantung kepada analisis rangkaian beban muatan trafik. Selain itu, bagi menjangka botnet baru, model pengesanan harus dibangunkan. Kajian ini bertumpu kepada penggunaan analisa tingkah-laku berdasarkan aliran bagi mengesan botnet baru yang sukar dikesan pada corak pengenalan botnet sedia-ada yang sentiasa berubah dan menggunakan strategi tersembunyi. Kajian ini juga mencadangkan penggunakan Analisis Komponen Bebas (ICA) dan pra-pemprosesan data yang standard bagi meningkatkan kualiti data sebelum pengelasan. Peratusan ciri-ciri penting telah dibandingkan dengan dan tanpa menggunakan ICA. Dapatan kajian melalui eksperimen menunjukkan dengan penggunaan ICA, keputusan adalah jauh lebih baik. Skor F tertinggi ialah 83% bagi bot Neris. Purata skor F bagi sampel botnet baru adalah 74%. Melalui ujian kepentingan ciri, kepentingan ciri meningkat dari 22% kepada 27%, dan kadar positif model latihan palsu juga berkurangan dari 1.8% kepada 1.7%.
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