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Regulatory Focus™ > News Articles > Perspective: What Do You Believe?

Perspective: What Do You Believe?

Posted 01 March 2009 | By Linda J. Bovard, RAC

Recently, I have found myself saying the same words to several different clients. This surprised me, as the clients were seemingly not at all alike and their products were in different stages of development. Where did these ideas come from? Did I really believe them? Were they actually applicable in a broad range of circumstances? I have decided that these are lessons I have learned over more than 25 years in the medical device regulatory field. I am sure some of them come from talks I have attended or stories I have heard, but most come from seeing what works and what doesn't. They are not principles or ethics, but more like best practices in a medical device company. I share them with you, not because I think they are universal, but to spark your own thinking about what your beliefs are. They are presented with apologies to our FDA colleagues. I have always worked in industry, never at FDA, so I am sure this skews my views.


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