MDR is very complex, this we know. And it is written in English, which can make for some very, shall we say, interesting interpretations when translated into other languages. It is not always a word-for-word transcription – or meaning.
In this clip, Greg Kunst and I discuss what can happen when just one word is misunderstood or misused in translation.
FDA regulations and your bottom line
FDA regulations change constantly. Know the changes, because being compliant means able to sell. And ‘able to sell’ means cash flow.
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Why Medical Device Software is NOT Just Software
Software is software is software, right? That’s what Jose Bohorquez and I hear from medical device companies all the time. Software for
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FDA Approval of Your Medical Devices: There’s No Escaping It, Might as Well Accept It
Acceptance: The Fifth Stage of Regulatory Grief (video) Let’s face it – no one likes being told what to do,
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Michelle Lott and the leanTeam help clients recognize regulatory and quality issues aren't a "burden" – they are strategic advantages when used properly. The expert team will also strip away any redundant or misdirected activities so you can focus on what really matters:
