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.
"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
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