Blog | Page 3 of 16 | Regulatory + Quality Assurance | Michelle Lott

Why do we need a document control process? Oh, if only I had a nickel for every time I’ve been...

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How do you determine the correct FDA submission for combination products? What IS a combination product? A combination p...

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Very few days go by without someone asking me to explain the differences between FDA submission types. This most often...

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If you think that getting a medical device onto market is a long and tedious process, be glad you don’t...

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Just over a year after COVID-19 put the world on hold, the powers that be have released a news brief...

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Customers ask me all the time – “Michelle, I keep hearing this term – supplier criticality. What does ...

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