fda-consultant-specialist

tessl i github:alirezarezvani/claude-skills --skill fda-consultant-specialist

Senior FDA consultant and specialist for medical device companies including HIPAA compliance and requirement management. Provides FDA pathway expertise, QSR compliance, cybersecurity guidance, and regulatory submission support. Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development.

57%

Overall

Validation — 81%

Implementation — 20%

Activation — 90%

SKILL.md

Review

Evals

Validation

81%

Warnings & errors only

Criteria	Description	Result
description_trigger_hint	Description may be missing an explicit 'when to use' trigger hint (e.g., 'Use when...')	Warning
metadata_version	'metadata' field is not a dictionary	Warning
license_field	'license' field is missing	Warning

	Total	13 / 16 Passed

Implementation

20%

This skill reads like a regulatory textbook rather than actionable guidance for Claude. It extensively documents FDA regulatory frameworks, HIPAA requirements, and QSR compliance structures that Claude likely already understands, while failing to provide concrete, executable guidance. The referenced scripts and templates could be valuable but none are actually shown or demonstrated.

Suggestions

Replace verbose framework descriptions with specific, executable examples - show actual script usage with sample inputs/outputs rather than just listing script names

Remove explanatory content about what FDA pathways, HIPAA, and QSR are - focus only on project-specific implementation details Claude wouldn't know

Add explicit validation checkpoints with concrete verification commands (e.g., 'Run qsr-compliance-checker.py and verify all items pass before proceeding')

Move detailed regulatory frameworks to reference files and keep only a concise decision tree or quick-reference in the main skill

Dimension	Reasoning	Score
Conciseness	Extremely verbose with extensive hierarchical frameworks that explain regulatory concepts Claude already knows. The ASCII tree diagrams and multi-level bullet lists add significant token overhead without providing actionable value beyond what Claude could infer from basic regulatory knowledge.	1 / 3
Actionability	Despite listing scripts like 'fda-submission-tracker.py', no actual executable code is provided. Content describes regulatory frameworks abstractly rather than providing concrete commands, specific examples, or copy-paste ready guidance. References to external files (e.g., 'Follow references/fda-capa-requirements.md') without inline actionable content.	1 / 3
Workflow Clarity	Some processes are sequenced (510(k) submission has numbered steps), but validation checkpoints are vague ('Decision Point: Determine submission readiness') rather than explicit verification steps. No feedback loops for error recovery in complex regulatory processes.	2 / 3
Progressive Disclosure	References external files appropriately (references/, scripts/, assets/) but the main content is a monolithic wall of hierarchical text. The skill would benefit from moving detailed frameworks to reference files and keeping only essential overview content in the main file.	2 / 3
	Total	6 / 12 Passed

Activation

90%

This is a solid skill description with clear domain focus on FDA medical device regulation. It includes explicit 'Use for' guidance and good trigger terms. The main weakness is that the capabilities could be more concrete - listing specific deliverables or actions rather than general areas of expertise would strengthen it.

Suggestions

Replace abstract capability phrases like 'Provides FDA pathway expertise' with concrete actions like 'Determines 510(k) vs PMA pathway, drafts predicate device comparisons, reviews clinical evidence requirements'

Add specific document types or deliverables: 'prepares submission checklists, reviews design history files, drafts cybersecurity documentation per FDA guidance'

Dimension	Reasoning	Score
Specificity	Names the domain (FDA/medical device regulation) and lists several action areas (pathway expertise, QSR compliance, cybersecurity guidance, submission support), but these are somewhat abstract rather than concrete specific actions like 'review 510(k) submissions' or 'draft predicate device comparisons'.	2 / 3
Completeness	Clearly answers both what (FDA pathway expertise, QSR compliance, cybersecurity guidance, regulatory submission support) AND when ('Use for FDA submission planning, QSR compliance assessments, HIPAA evaluations, and FDA regulatory strategy development') with explicit trigger scenarios.	3 / 3
Trigger Term Quality	Good coverage of natural terms users would say: 'FDA', 'HIPAA', 'QSR', 'medical device', 'regulatory submission', 'compliance', 'cybersecurity'. These are terms professionals in this domain would naturally use when seeking help.	3 / 3
Distinctiveness Conflict Risk	Very specific niche targeting FDA medical device regulation with distinct triggers (FDA, QSR, HIPAA, medical device). Unlikely to conflict with general compliance or healthcare skills due to the specific regulatory focus.	3 / 3
	Total	11 / 12 Passed

Reviewed

16 days ago

Table of Contents

Validation Implementation Activation

Is this your skill?

If you maintain this skill, you can claim it as your own. Once claimed, you can manage eval scenarios, bundle related skills, attach documentation or rules, and ensure cross-agent compatibility.