Subscribe to Email Updates

Quality Creates...Perspective

FDA Compliance, Medical Devices, Product Recall

FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk

 

HBO's recent expose on the medical device industry flagged up some quality and compliance issues. 

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Sep 17, 2019
   
FDA Cleared vs. FDA Approved: Why the 510(k) System Is Broken and How Medical Device Manufacturers Can Reduce Risk

 

HBO's recent expose on the medical device industry flagged up some quality and compliance issues. 

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Tue, Sep 17, 2019
Quality Matters: Papayas, Pig Ears And Trampolines ... All Part Of August's QMS Landscape

 

Summer is over, but product recalls are not affected by the changing of the seasons. 

David Bolton
By David Bolton
on Wed, Sep 04, 2019
Why Safety Compliance Must Be A Quality Priority For Carmakers

The auto industry is always touting the continuous improvement in the driving experience, but missing parts can be a problem.

David Bolton
By David Bolton
on Wed, Aug 14, 2019
Quality Matters: QMS Never Takes A Vacation

 

Frogs, fish, fire and the daily work of the FDA ... just some of the QMS topics that surfaced in July. 

David Bolton
By David Bolton
on Wed, Aug 07, 2019
Quality Matters: Dispatches From The QMS Front Line

 

Quality is under pressure every day. Our new monthly round-up provides a few highlights. 

David Bolton
By David Bolton
on Mon, Jul 01, 2019
Report: 64 Percent Of Electronics Manufacturers Have Product Quality Issues

 

Complex hardware plus short product lifecycles equals quality management problems.

David Bolton
By David Bolton
on Tue, Jun 25, 2019
Farouk Systems: Doing the Right Thing by Understanding the “Speed of Quality.”

Product recalls are never welcome, but quality wins when the recall is done right.  

Rob Gremley
By Rob Gremley
on Tue, May 28, 2019

Leave a comment

Written by
Written by Author