Understanding medical devices
Explore medical devices through intended use, operating principles, performance and use environments, and frame questions for product development.
Medical devices
What Does DMA Measure: From Equipment Structure to E′·E″·tan δ Graphs
This article explains the structure and measuring principles of DMA equipment, along with examples of calculating storage modulus, loss modulus, and tan δ graphs.
Medical devices The Starting Point of Biological Evaluation: Contact Conditions of Skin Pads and Blood Pathways This article compares virtual skin pads and blood pathway tubes using the same silicone, explaining how to connect contact surfaces, usage time, frequency of use, and final product conditions to a biological evaluation plan.
Medical devices Reading DSC Curves: Glass Transition, Melting, and Thermal History How do we distinguish between steps and peaks when comparing DSC results of polymer components? This article organizes the sequence of interpretation using three figures and a virtual lot comparison case.
Medical devices Developers Use It Easily, But Do New Users? This article explores usability review questions considering users, usage environments, and device operations.
It connects observed behaviors from a hypothetical portable measuring device to design improvements and validation evidence.
Medical devices Sterile Device Packaging: What to Check Beyond the Shipping Box This practical question connects the final packaging composition and distribution conditions with post-transportation verification items.
It examines the application scope of existing validation evidence through a hypothetical scenario involving a change in cushioning material.
Medical devices Better Performance Test Results? Check the Comparison Conditions First What should we check before interpreting differences in the performance test results of medical devices as design improvements? We will organize practical examples of comparing two reports and review notes, distinguishing differences in test subjects and methods.
Medical devices Three Questions for Understanding Medical Devices: Purpose of Use, Operating Principle, Performance This article examines why knowing the product name or specification alone is insufficient for understanding medical devices.
It divides the questions into purpose of use, operating principle, and performance, and connects product descriptions and verification questions using hypothetical measuring device examples.
Medical devices The Starting Point of Biological Evaluation: Contact Conditions of Skin Pads and Blood Pathways This article compares virtual skin pads and blood pathway tubes using the same silicone, explaining how to connect contact surfaces, usage time, frequency of use, and final product conditions to a biological evaluation plan.
Medical devices Reading DSC Curves: Glass Transition, Melting, and Thermal History How do we distinguish between steps and peaks when comparing DSC results of polymer components? This article organizes the sequence of interpretation using three figures and a virtual lot comparison case.
Medical devices Developers Use It Easily, But Do New Users? This article explores usability review questions considering users, usage environments, and device operations.
It connects observed behaviors from a hypothetical portable measuring device to design improvements and validation evidence.
Medical devices Sterile Device Packaging: What to Check Beyond the Shipping Box This practical question connects the final packaging composition and distribution conditions with post-transportation verification items.
It examines the application scope of existing validation evidence through a hypothetical scenario involving a change in cushioning material.
Medical devices Better Performance Test Results? Check the Comparison Conditions First What should we check before interpreting differences in the performance test results of medical devices as design improvements? We will organize practical examples of comparing two reports and review notes, distinguishing differences in test subjects and methods.
Medical devices Three Questions for Understanding Medical Devices: Purpose of Use, Operating Principle, Performance This article examines why knowing the product name or specification alone is insufficient for understanding medical devices.
It divides the questions into purpose of use, operating principle, and performance, and connects product descriptions and verification questions using hypothetical measuring device examples.