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Showing posts from December, 2024

IoT Technologies , Protocols, stacks, resources

A. Examples of IoT applications from different industries for each specified element: Actuators Industry: Automotive Example: Automatic Braking Systems in Vehicles Actuators are used in automatic braking systems to apply pressure to the brake pads when a collision risk is detected. Sensors monitor proximity, speed, and environmental changes, and the actuator responds by engaging the braking mechanism to prevent a collision. Embedded Systems Industry: Healthcare Example: Wearable Health Monitoring Devices Embedded systems are used in wearable devices like smartwatches or fitness trackers. These devices monitor vital signs (e.g., heart rate, blood pressure) using sensors and process the data using microcontroller-based embedded systems to provide insights into a user’s health in real-time. Intelligent Devices Industry: Agriculture Example: Smart Irrigation Systems Intelligent devices in smart agriculture use IoT capabilities to optimize irrigation schedules. These devices compute soil mo...

Medical device Common Technical Document (CTD) application. US and EU

 The Common Technical Document (CTD) is a standard format for presenting data in an Investigational New Drug (IND) application to the FDA Includes a good Graphic. How to handle your Medical Device Technical Documentation? – Part 1: Basic definitions https://www.debiotech.com/how-to-handle-your-medical-device-technical-documentation-part-1-basic-definitions/ From FDA :  (a) Electronic Common Technical Document (eCTD) https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd (b) Guidance document. FAQs. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m4-ctd-general-questions-and-answers Ref https://www.bioduro.com/news-resources/insights/common-technical-document.html#:~:text=The%20Common%20Technical%20Document%20%28CTD%29%20is%20a%20standard,ensuring%20consistent%20and%20comprehensive%20information%20for%20regulatory%20review. Additionally: How to CE Mark a Medical Device that Incorporates a Dru...