cyberneticlibrary
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Prepare FDA and CE mark submissions

regulatory-affairs-headskillsetup L3★17,464
alirezarezvani/claude-skills ↗
What it does

Prepare FDA/EU submissions and regulatory strategy for medical devices

Best for

MedTech companies navigating 510(k), De Novo, PMA, or CE marking pathways.

Inputs
  • · [object Object]
  • · [object Object]
  • · [object Object]
Outputs
  • · [object Object]
  • · [object Object]
  • · [object Object]
Requires
  • · FDA CDRH database
  • · EU EUDAMED
  • · Notified Body integrations
Preconditions

Device classification determined; intended use statement drafted; predicate identified (if applicable).

Failure modes
  • · Predicate delisted mid-submission
  • · Notified Body audit backlog (6+ month delay)
  • · FDA deficiency letter on missing biocompatibility
  • · New technology triggers De Novo instead of 510(k)
Trust signals
  • · Pathway selection matrix (510(k) vs. De Novo vs. PMA)
  • · Regulatory strategy document template
  • · Workflow for Q-Sub meeting and pre-submission strategy