ISO 13485 Implementation Plan

The Objective Implementation plan to achieve compliance with the ISO 13485:2016 standard (Medical devices — Quality management systems — Requirements for regulatory purposes). Primary Focus of the Project: Research and determination of the ISO 13485:2016 Compliance Requirements. Gap Analysis and determination of where we need to improve or implement new controls. Prepare documentation Requirements in ISO 13485

Electrical Circuit Design for a Medical Device

Main Goal for the Project: The main goal of this project is to develop and refine the hardware and software components of the Pocket Clinic smart injector, ensuring it meets all functional and regulatory requirements. Problem Learners Will Be Solving: Learners will address the challenge of designing and coding the electronic boards for the smart injector. This involves creating schematics, selecting appropriate components, designing the PCB, and developing the firmware to ensure seamless operation of the device. Expected Outcome by the End of the Project: By the end of the project, learners are expected to achieve the following outcomes: Hardware Development: Design electronic boards that meet the specific requirements of the Pocket Clinic smart injector. Create detailed schematics and select the appropriate components for optimal performance. Successfully design and fabricate the printed circuit boards (PCBs). Software Development: Develop and debug firmware to ensure the smart injector operates efficiently and accurately. Implement coding solutions that enhance the functionality and reliability of the device. Ensure seamless integration between the hardware and software components for optimal performance. Overall, learners will gain comprehensive experience in both hardware and software aspects of medical device development, contributing to the successful creation of the Pocket Clinic smart injector.