Quality Is, Above All, a Process That Protects and Makes Effort Visible
April 21, 2026 True quality is built not only in the final product, but at every step of the process….
Medical Device QMS
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Electronic Protection Systems in Medical Devices: The Foundation of Safety and Performance
10 June, 2025 Introduction: Why Are Protection Systems Important? Medical devices, especially sensitive and performance-critical equipment such as surgical power…
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Validation Process of Translation Programs Used in Medical Device QMS Documents
25 February, 2025 Translation programs used in Medical Device Quality Management Systems (QMS) documents are of great importance, especially for…
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Chemical Characterization in Medical Devices: Biological Safety and Risk Management
06 August, 2024 Material selection and risk analysis before the production of surgical saw blades is the most important part…
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How is usability engineering applied in medical devices?
08 June, 2023 Introduction to Usability in Medical Devices Usability research looks at the interactions between human operators and the…
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Transition Period to MDR
14 August, 2022 The European Medical Device Regulation (MDR) has brought harmonization for many medical device manufacturers. However, the transition…
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How is the number of medical device test samples determined?
12 September, 2023 How is the number of medical device test samples determined? The reliability and effectiveness of medical devices…
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How challenging can the working conditions of electronic medical devices be?
23 September, 2022 We know that electronic medical devices are sensitive to water, temperature and pressure. For example, when using…
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Literature Review on Medical Devices
06 September, 2022 Literature is all of the writings and works written in any branch of science. (Google’s Turkish Dictionary/…
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2017/745 MDR Harmonized Standards
28 April, 2022 What are the 2017/745 MDR Harmonized Standards? In this article, we are going to give you the…
