Regulatory Milestone Planning Skill

Purpose

Generate phase-based regulatory project plans with milestones, dependencies, and critical path analysis. This is a pure analysis unit that receives pathway and estimation data and returns a structured project plan.

Input: Pathway and estimation results (selected pathways, cost/timeline estimates per region) Output: Milestone plan with phases, deliverables, dependencies, critical path, traffic light indicator Knowledge Base Date: 2026-01

Planning Framework

Phase Structure

All regulatory plans follow a standard 4-6 phase structure:

1. •

   Preparation

   • •Gap analysis
   • •Resource allocation
   • •Strategy finalization
2. •

   Testing & Validation

   • •Biocompatibility testing
   • •Performance testing
   • •Electrical safety testing
   • •Software validation (if applicable)
3. •

   Documentation

   • •Technical file creation
   • •Submission package assembly
   • •Clinical evaluation report (if applicable)
4. •

   Submission & Review

   • •Regulatory submission
   • •Deficiency response
   • •Approval/certification
5. •

   Clinical Study (if applicable)

   • •Protocol development
   • •IRB approval
   • •Patient enrollment
   • •Data collection and analysis
6. •

   Post-Market (optional in initial plan)

   • •Post-market surveillance setup
   • •Vigilance system implementation

Dependency Types

Sequential Dependencies

• •Hard Dependency: Task B cannot start until Task A completes
  • •Example: "Documentation" depends on "Testing completion"
  • •Notation: A -> B

Parallel Dependencies

• •Shared Resource: Tasks can run in parallel but share common inputs
  • •Example: FDA and EU submissions both depend on "Common Testing"
  • •Notation: C => A, C => B

Milestone Dependencies

• •Checkpoint: Multiple tasks must complete before next phase begins
  • •Example: All testing must finish before documentation starts
  • •Notation: [A, B, C] => D

Plan Templates by Pathway

Multi-Region Planning

Parallel Submission Strategy

When submitting to multiple regions simultaneously:

Shared Phases (run once, benefit all):

• •Common Testing (biocompatibility, electrical safety, performance)
• •Clinical data collection (if shared across regions)

Region-Specific Phases (run in parallel):

• •FDA 510(k) documentation
• •EU MDR technical file
• •MFDS approval application

Dependency Map:

Common Testing -> FDA Documentation -> FDA Submission
              -> EU Documentation -> EU Submission
              -> MFDS Documentation -> MFDS Submission

Critical Path: Region with longest review time

Sequential Submission Strategy

When staggering submissions (e.g., US first, then EU/Korea):

Phase Order:

1. •Common Testing
2. •FDA Submission -> FDA Approval
3. •EU Submission (using FDA approval data)
4. •MFDS Submission (using FDA/EU data)

Advantage: Later submissions can reference earlier approvals Disadvantage: Longer total timeline

Analysis Workflow

Step 1: Receive Input Data

Accept pathway and estimation results as input:

• •Selected pathways per region
• •Cost/timeline estimates per region
• •Target regions

If input data is not provided, return an error indicating pathway and estimation analysis are required first.

Step 2: Select Plan Template

Based on pathway data, select appropriate template:

• •510(k) -> 4-phase plan
• •PMA -> 4-phase plan with clinical trial
• •De Novo -> 4-phase plan with special controls
• •EU MDR IIa/IIb -> 3-phase plan with Notified Body
• •MFDS Grade 1-2 -> 4-phase plan
• •MFDS Grade 3-4 -> 5-phase plan with clinical data/trial

Step 3: Map Milestones to Timeline

Using timeline estimates:

• •Assign duration to each phase (optimistic, expected, pessimistic)
• •Calculate cumulative timeline
• •Identify phase dependencies

Step 4: Multi-Region Integration

If multiple target regions:

• •Identify shared phases (common testing)
• •Determine parallel vs. sequential strategy
• •Map dependencies across regions
• •Calculate critical path

Step 5: Assign Traffic Light

• •GREEN: Total timeline < 12 months, no clinical study, low complexity
• •YELLOW: Timeline 12-24 months or clinical study required or multi-region complex dependencies

Step 6: Return Structured Result

Return the project plan containing:

• •Phase-by-phase breakdown with durations
• •Deliverables per phase
• •Dependencies map (sequential, parallel, milestone)
• •Multi-region integration plan (if applicable)
• •Critical path identification
• •Key milestones with estimated dates
• •Risk factors and mitigation strategies
• •Traffic light assessment

Traffic Light Definitions

• •GREEN: Total timeline < 12 months, no clinical study, single or dual-market, low complexity
• •YELLOW: Timeline 12-24 months, clinical study required, or multi-region with complex dependencies
• •RED: Not used (all plans are feasible with appropriate resources)

Data Source Strategy

1. •Built-in Knowledge (Primary): Phase templates and dependency frameworks
2. •Pathway Data (Input): Pathway selection results from pathway skill
3. •Estimation Data (Input): Cost/timeline estimates from estimation skill

For MCP integration patterns (tool discovery, graceful degradation, source attribution), see CONNECTORS.md.