Why 20/20 Strategic Vision?

Where do you want to be 10 years from now? How do you plan to get there? By focusing on being a catalyst, making connections, and creating value through product and services, you can establish a strategy that will yield success through 2020 and beyond. Contact us to learn how we can help you! … Read More

Indiana Life Science Organizations

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Medical Device Product Development Is A Linear Process

May 16, 2013

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

May 14, 2013

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 [...]