Items Tagged with 'validation'

Sai Ranjith Ramakrishnan Kumar (Sai) is a medical device quality engineering expert, Six Sigma Green Belt Certified, and programs chair of ASQ Granite State Section. Quality talked with him about his contributions to advancing quality practices in industry and beyond, focusing on enhancing patient safety, ensuring regulatory compliance, and driving innovation in the profession.

A race inspired Dr. Rochelle Cook to share her insights on validation studies, also known as pilots. This type of trial can benefit manufacturers in a variety of ways, by testing a process, system, or product.

What level of quality do you feel is required in orthopedic implants, pacemakers and other critical, life-sustaining medical devices? The highest quality, of course!

Quality and compliance are all about consistency and repeatability. Change is often seen as a risk. These are times of dramatic change, with a new digital manufacturing paradigm and ongoing pandemic both accelerating the rate of transformation.

Why conduct these tests? There are many reasons to perform materials tests. Data from testing can be used by engineers, scientists, designers, and managers. 

The term machine vision can imply a computer having a set of eyes for an inspection. To develop a complete solution for machine vision applications, vision engineers execute a series of tasks that usually fall into five categories: plan, design, build, integrate, and validate.