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IEC 62304 Requirements MCP Server

IEC 62304 Requirements MCP Server

by Pakawat-Dev
OverviewSchemaSourceRelated ServersDiscussionsAdmin
Python
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create_risk_control

Create risk controls with calculated risk levels from hazard severity and probability, and link them to requirements for ISO 14971-compliant medical device development.

Instructions

Create risk control with requirement linkage (ISO 14971 integration)

Args: risk_id: Unique risk ID (e.g., RK-001) hazard_description: Description of the hazard severity: Catastrophic, Critical, Marginal, or Negligible probability: Frequent, Probable, Occasional, Remote, or Improbable control_measures: Risk mitigation measures description requirement_id: Linked requirement ID (optional)

Returns: Success message with risk ID and calculated risk level

Tool call template

Replace each placeholder with a value matching the input schema. Only required parameters are included; add optional parameters as needed.

{
  "id": 1,
  "jsonrpc": "2.0",
  "method": "tools/call",
  "params": {
    "arguments": {
      "risk_id": "<risk_id>",
      "hazard_description": "<hazard_description>",
      "severity": "<severity>",
      "probability": "<probability>",
      "control_measures": "<control_measures>"
    },
    "name": "create_risk_control"
  }
}

Input Schema

NameRequiredDescriptionDefault
risk_idYes
severityYes
probabilityYes
requirement_idNo
control_measuresYes
hazard_descriptionYes

Output Schema

NameRequiredDescriptionDefault
resultYes

Schema Changelog

Changes observed during successful MCP inspections.

  1. First observedv1.0.0

TDQS

A4.3/5.0
Behavior3/5

Does the description disclose side effects, auth requirements, rate limits, or destructive behavior?

With no annotations, the description must carry the full burden. It states the tool creates a risk control and returns a success message with a calculated risk level, which gives useful behavioral context. However, it does not disclose prerequisites (e.g., requirement existence), authorization needs, or side effects beyond creation, leaving room for more transparency.

Agents need to know what a tool does to the world before calling it. Descriptions should go beyond structured annotations to explain consequences.

Conciseness5/5

Is the description appropriately sized, front-loaded, and free of redundancy?

The description is well-structured with a clear purpose, an Args list, and a Returns section. Every line adds value, avoids redundancy, and front-loads the core function. It is appropriately sized for the tool's complexity.

Shorter descriptions cost fewer tokens and are easier for agents to parse. Every sentence should earn its place.

Completeness4/5

Given the tool's complexity, does the description cover enough for an agent to succeed on first attempt?

The description is sufficiently complete for a creation tool with an output schema. It provides an overview of inputs, the return format, and the ISO 14971 context. It could optionally mention that requirement_id is optional and what happens if omitted, but this is a minor gap given the moderate complexity.

Complex tools with many parameters or behaviors need more documentation. Simple tools need less. This dimension scales expectations accordingly.

Parameters5/5

Does the description clarify parameter syntax, constraints, interactions, or defaults beyond what the schema provides?

Schema description coverage is 0%, so the description fully compensates by providing meaningful explanations for all six parameters. It lists allowed values for severity and probability, which is essential and not present in the schema. Each parameter gets a concise, useful description, going well beyond the schema's bare titles.

Input schemas describe structure but not intent. Descriptions should explain non-obvious parameter relationships and valid value ranges.

Purpose5/5

Does the description clearly state what the tool does and how it differs from similar tools?

The description uses a specific verb+resource construction ('Create risk control') and adds the ISO 14971 integration context. This clearly distinguishes it from sibling tools that all focus on requirements and documents, making the tool's purpose unambiguous.

Agents choose between tools based on descriptions. A clear purpose with a specific verb and resource helps agents select the right tool.

Usage Guidelines4/5

Does the description explain when to use this tool, when not to, or what alternatives exist?

The description implies usage for creating risk controls within an ISO 14971 framework. While it does not explicitly list alternatives or exclusions, the context is clear enough given that siblings are requirement-focused. The lack of explicit 'when to use' is a minor gap.

Agents often have multiple tools that could apply. Explicit usage guidance like "use X instead of Y when Z" prevents misuse.

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