Karen Boyd, ASQ CQA Jeff, did you begin or locate FDA's Design Control Guidance document? If not, here is a link - http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070642.pdf.

Jeff Schreiber Yes I did happen to see that, I guess my question is are there any examples of these forms out there, or perhaps maybe a fill in sheet. I would like to make my forms look professional and up to FDA standards.

Karen Boyd, ASQ CQA Based on the recommendations in that FDA guideline, FDA submission requirements, and any customer, product, or design class requirements, you could create a basic matrix or Excel chart to organize the information [including each design characteristic / function / requirement, then input for each, output for each, acceptance criteria - how output meets input, and verification / validation evidence - drawing, spec, test result, etc.].

Julie Omohundro There is no required format, but they are typically in the type of Excel format Karen refers to. I can send you a template. My email address is in my LinkedIn profile under the Contact Info tab.

Jeff Schreiber Yes that would be very helpful Julie. I am not seeing your contact info on your page. I will message you my email address instead. Thank you!!

Julie Omohundro It's tucked away where no one can find it. So LinkedIn. :)

Daniel Feller Jeff, did anyone pass along examples of requirement decomposition and expression? If you still need some examples I can email to you.

Jeff Schreiber Hey Daniel, Julie said she would send me a template but I definitely will take more examples if you are able to send them, it will give me a better understanding of what the FDA expects. My email address is on my LinkedIn page. Thank you everyone for your input.

Julie Omohundro Jeff, I hope you received the template.

Jeff Schreiber Yes thank you