Top Regulatory Tips: Tips 1 & 2

Monday, March 09, 2009

Part 1 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Next:
Tips 3 & 4 »


I developed a "10 Top Tips" list for the last version of our website. I decided it's time to dust that off, spruce it up and offer it as a series of blogs. I'll be giving out two a day for the next five days ... stay tuned!

 

Tip 1: Make regulatory part of your business plan

FDA is one of your most important customers; take their needs into consideration during product development. Even if you don't plan to approach the diagnostic market for a few years, it's worth it to plan ahead and make sure your ready for the day when it's time to go that direction. Plus, your investors will ask for these plans. It'll be much better to be prepared with realistic regulatory plans that investors can get behind.

 

Tip 2: Begin with design control

Document deisgn decisions and changes with justifications from the beginning of development. And assume development begins when you start seriously writing down product requirements. Allowing informal, lightly documented systems go on too long will create trouble when it's time to get to the market. It may not be the most fun ever but it'll pay off later on.

 

Stay tuned for Tips 3 and 4 tomorrow!

Tags: Best Practices, FDA, FDA 101, QSR

Part 1 of Top Regulatory Tips

View part: [ 1 | 2 | 3 | 4 | 5 ]

Next:
Tips 3 & 4 »


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Dylan Reinhardt
Dave Kern
Steve Gutman
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