Preview release — SaMD Clarity is under active development.

SaMD Clarity

Regulatory clarity for software projects — before you build.

Confirm regulatory scope and translate it into risk, complexity, and documentation implications under EU MDR.

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Module 1 — Context & Classification

Eliminate regulatory ambiguity before you commit.

  • SaMD / Not SaMD conclusion
  • MDR Rule 11 class (I / IIa / IIb)
  • Clear rationale and scope boundary
Fast, deterministic

Interprets intended use and system behavior, resolves ambiguity or contradictions, and confirms regulatory scope with a clear explanation.

Module 2 — Risk, Complexity & Technical Scope

Translate classification into real-world implications.

  • IEC 62304 software class (A / B / C)
  • High-level hazard seed themes
  • Complexity & documentation scope
Turns classification into scope

Determines IEC 62304 class, identifies hazard clusters, assesses complexity, and maps relevant Annex I GSPRs — before development starts.

How SaMD Clarity Works

Deterministic logic, supported by intelligent interpretation.

Rules Engine

(Decision Logic)

  • MDR Rule 11 logic
  • IEC 62304 classification
  • Annex I GSPR mapping
  • Repeatable outcomes

AI Interpretation Layer

(Clarification & Validation)

  • Interprets free-text intent
  • Detects ambiguity
  • Requests clarification only when needed
  • Prevents false certainty

What SaMD Clarity does NOT do

SaMD Clarity provides clarity — not guarantees.

Output

Each assessment generates a concise PDF report.

Get clarity before you build.

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