Subscribe to Email Updates

Quality Creates...Perspective

Quality Management, FDA Compliance, Medical Devices

Using Quality Management Software Tools to Manage Recalls

There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing Recall Management. Let's face it—no one likes talking about recalls; there is no positive side to recalls, and certainly no one "wins" when a product is recalled. This is a double whammy when you are a medical device manufacturer—not only are you recalling a defective product, but you are also facing regulatory scrutiny and potential customer endangerment. So when I speak about medical device recalls, many are apt to have a system in place to manage processes in the unfortunate event of a recall. The critical factor in this case is what system is best suited to effectively and efficiently manage the recall process?

Tim Lozier
By Tim Lozier
on Fri, Jul 13, 2012
   
Using Quality Management Software Tools to Manage Recalls

There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing ...

Tim Lozier
By Tim Lozier
on Fri, Jul 13, 2012
3 Things you Need to Know about Validating QMS in the Cloud

As technology evolves, more companies are looking for easier ways to manage their IT infrastructure and, in turn, their ...

Tim Lozier
By Tim Lozier
on Thu, Mar 29, 2012
FDA FSMA Regulations Delayed: Don't Wait for Food Safety Management!

Last year, we all waited with anticipation when the Food Safety Modernization Act was signed.  This marked an evident step...

Tim Lozier
By Tim Lozier
on Fri, Feb 24, 2012
5 Things the FDA must do for Food Safety Management in 2012

The title of this blog really should be "5 Things the FDA Probably Won't do for Food Safety Management in 2012."

Tim Lozier
By Tim Lozier
on Thu, Jan 19, 2012
eMDR Final Rule Date Still Unknown, but Submissions are on the Rise

I have to admit, I was hoping to post a blog today announcing the final rule date for the Electronic Medical Device...

Tim Lozier
By Tim Lozier
on Thu, Oct 06, 2011
3 Reasons to Adopt Automated Validation in Quality Management Systems

My daughter has been learning how to ride a bike for the past year.  She's actually become quite adept at it, and for...

Tim Lozier
By Tim Lozier
on Wed, May 04, 2011
Quality Management Seminar Wrap-Up: Risk and Harmonization , Part 1

This past week, we finished up a in-depth seminar in New Jersey.  The seminar, focused in the Life Sciences market, touched...

Tim Lozier
By Tim Lozier
on Mon, Apr 18, 2011

Leave a comment

Written by
Written by Author