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Quality Creates...Perspective

FDA Compliance, Healthcare, product safety

Medical Device Security: Ongoing Threats And New FDA Guidance

 

Connected medical devices are raising the cybersecurity stakes ... 

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Oct 18, 2019
   
Medical Device Security: Ongoing Threats And New FDA Guidance

 

Connected medical devices are raising the cybersecurity stakes ... 

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Oct 18, 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
Integrating Regulatory Content to your Compliance Management Systems
These days, the term "real-time" has almost become useless as a descriptive element.  Everything we do in our digital lives...
Tim Lozier
By Tim Lozier
on Wed, Feb 06, 2013
And So It Begins: New Rules from the FDA on Food Safety Management

It's a new year, and with it comes new and exciting challenges.  Have you ever got that feeling when you come back from...

Tim Lozier
By Tim Lozier
on Fri, Jan 11, 2013
The Fiscal Cliff's Impact on Food Safety Management and the FSMA

I've only been peripherally following the political world in the past few months.  There was apparently an election I'm...

Tim Lozier
By Tim Lozier
on Fri, Dec 07, 2012
Automated Validation Interest Grows for Quality Management Solutions

There's the old saying, "Don't knock it until you try it."  My daughter was convinced that broccoli was yucky, and she...

Tim Lozier
By Tim Lozier
on Fri, Sep 14, 2012
All I Need to Know About Food Safety Management I Learned in Kindergarten

Food Safety and Food Quality are growing topics in the industry and within regulators.  Whether it’s implementing one of...

Tim Lozier
By Tim Lozier
on Fri, Aug 03, 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

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