Blog | Regulatory and Quality Assurance | Michelle Lott

I’ve said it time and time again – the FDA pre-submission is a valuable tool for companies seeking FDA approval...

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Imagine this: you’ve just completed biocompatibility testing for your device, and the data looks great. You assemble t...

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QMSR and ISO 13485 – talk about a tale of two regulations. QMSR and QSR do sound practically the same,...

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Congratulations – after years of pouring your heart, soul and ingenuity into the project, you’ve developed a...

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Today we’re talking about the third step in the five steps to market process – determining the right class a...

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Can you name the five steps to market required to move your product from concept to launch? Obviously, we’re talki...

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