ISO 13485

What has been included in the new ISO 13485:2016?

What has been included in the new ISO 13485:2016?

This is a guest post by Dr. Michael Rinck, founder and managing director of MT Promedt Consulting.

 

The International Organisation for Standardisation (ISO) released its long-awaited revision to the ISO 13485. This global standard for medical device quality management systems (QMS), is replacing the previous ISO 13485:2003. 

Why You Can’t Ignore Usability Engineering

Why You Can’t Ignore Usability Engineering

A product should work well for its user with as minimal guidance as possible. People do not wish to spend much of their time trying to figure out how to use the product or worse, use a product that do not really serve its purpose. This is why usability engineering is becoming more important over the years and definitely playing a big role now in the medical device industry.