top of page
Get Started
Its easy to begin structuring files for Quality System Regulations.
Gather and group existing information you've already made like:
-
Pitch/Investor slide set
-
Customer input (Customer Canvas, Minimum Viable Product description)
-
Marketing materials, manuals, etc.
-
Use models; target population personas/demographics; first user responses
-
Competitive threat/response analysis
-
High level “project plan”
-
Requirements/Specifications
-
Value proposition feedback
-
Risk Assessment
-
Sales channels
-
In house/contract design-build drawings and documentation
-
Concept model/prototype
-
Available user and/or clinical study data
-
FDA discussions
-
Don't create new, potentially unneeded documents
bottom of page