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

We are developing a biosensor for various chronic diseases. Currently, we are looking for a team of students who can get involved in a smaller part of the project where we need to develop the mechanical assembly along with the required electronics and software. The goal of this project is to improve upon a currently existing and operational (but not optimized) electrical system within a hardware product and assist in the assembly and testing of a new electronic hardware product. The product is a smart injector with sensors and a microprocessor for drug delivery. We hope the student will learn more about electronics design, testing protocols, and quality assurance. The improvements will be evaluated by a number of factors including safety of the design, regulatory compliance, cost reduction, simplification (reduction in component numbers or size), and quality of components/suppliers chosen.