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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

  • Contact IMC

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Call: 978-509-1630

 

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