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Medical Device Product Development Is A Linear Process

If you believe this title, you have not worked on many medical device product development projects. But interestingly, FDA design control regulations and ISO 13485 design & development requirements convey the process as a linear progression. And most every product development and design control procedures I’ve read (and written) also lay out medical device product [...]

Time to Play Design Control Catch Up

I’ve written plenty of design control procedures. I understand FDA design control regulations very well. I’ve trained dozens of engineers and medical device professionals on the “rules” of design control. When to document, how to document, why to document. And now I’m up to my eyeballs on a startup medical device product development project realizing [...]