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Has Validation Visited You?

Joe Davis and his brother have been around machining for most of their lives.

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Joe Davis and his brother have been around machining for most of their lives. Early on, they bet on medical machining as a growth industry in need of reliable and capable suppliers. It was a good bet. Today, the shop employs 135 people.

Joe Davis owns 3-D Medical Machining, a shop in Rivera Beach Florida. I had the pleasure of visiting him for an article earlier this year. My focus for the story was to find out how Joe and his brother built their business from a couple cam Swiss machines to the shop full of Citizen CNCs that it is today.

As sometimes happens during these visits, I came away with more information than I was seeking. Specifically, Joe told me about an initiative from the FDA to establish validation of the machining processes for medical machine shops.

Joe has some views on this that I felt compelled to include in the article I wrote. If you are doing medical machining in your shop, and haven’t yet had the pleasure of an FDA inspection, you might want to read what Joe has to say about it. It’s coming.

My question to you is: Have you heard of FDA validation? E-mail your reply.