Save over $200k and 18 months in FDA preparation.

Streamline your FDA/EU preparation by doing it yourself.

Our do-it-yourself kits include templates required by the FDA, along with associated processes, training, guidance, and best practices to help you complete your design history file.

Required. Affordable. Easy to use.

"The Software Architecture template was a massive time-saver for us. The document is comprehensive, clearly organized, and gave my team the guidance necessary to customize our document by emulating the original content structure." 

-  Peter Holmes, COO, Barefoot Solutions

Want to learn more?

Our experts are happy to tell you about our premium (diy) Regulatory Kit's:

  •    Low Cost Access
  •    Automated Design Controls
  •    Continuously Updated Content
  •    On-Demand Training
  •    Monthly Support