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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
Why FDA Compliance Needs A Defined CAPA Process.

 

CAPA problems continue to bug medical device manufacturers as FDA inspections increase. 

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, Sep 06, 2019
How To Map Your QMS To EU MDR Requirements

 

The EU's revision of medical device legislation was long overdue ... but what is the impact?

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Fri, May 31, 2019
Webinar: How To Prepare For FDA Migration To ISO 13485 And MDSAP

 

ISO 13485 and MDSAP ... moving towards international harmony in the medical devices sector.

David Bolton
By David Bolton
on Mon, May 06, 2019
4 Quality Lessons Medical Device Manufacturers Can Learn from Tech Giants

Patient-centricity is a buzzword in life sciences, part of a push for innovation made difficult by complex regulations and...

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Thu, Sep 06, 2018
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 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

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