Week 12 Report

Group 5 - Eric Kong, Ayush Kumar, Luna Yang

Week 12 report

 

This week, we spent most of our the time reading and exploring the documents Mr. Trincal shared with us regarding the design of the leak pressure tester.

 

We also read official regulation documents regarding the quality management system and validation/verification process of medical devices to better understand what we need to keep in mind in order for our final design to be approved.

 

We also read about documents that are related to different parts of the pressure tester, such as the JE-222 imaging machines that are used for barcode reading, and the exact dimension of the clamp of the pressure tester (shown below), which would be useful when we consider re-design the clamp.

 

Our initial idea was to utilize an automated clamping system;however, this would require expensive hydraulics which is out of our scope. As a result, we will continue to look for ways that will make the clamp easier to use manually.