fda-consultant-specialist

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QMSR (21 CFR 820, which incorporates ISO 13485:2016 by reference since 2026-02-02; formerly QSR) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Quality

86%

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Quality

Content

78%Weight 40%Scale 1-5

Reviews the quality of instructions and guidance provided to agents. Good implementation is clear, handles edge cases, and produces reliable results.

A well-organized regulatory skill body with strong progressive disclosure and clear multi-step workflows. The lowest-scoring dimensions are conciseness, actionability, and workflow clarity, all sitting at 4 due to minor over-explanation, some descriptive-vs-instructional tables, and absence of explicit fix→retry feedback loops.

Suggestions

Tighten the QMSR transition blockquote into a compact mapping table or a short 'deprecated numbering' note to reduce token load without losing the regulatory detail.

Convert descriptive tables (e.g., Required Sections, Premarket Requirements) into actionable checklists or script invocations so Claude knows exactly what to produce rather than what is required.

Add an explicit validate→fix→retry feedback loop to the 510(k) Submission Process (e.g., after an RTA/AI, 'fix flagged sections → resubmit → re-check acknowledgment') to lift workflow clarity to 5.

Dimension	Reasoning	Score
Conciseness	Lean tables, decision trees, and ASCII workflows assume Claude's regulatory knowledge; the QMSR transition blockquote and a few prose caveats could be trimmed but are largely justified, sitting just below the fully-lean 5.	4 / 5
Actionability	Provides concrete decision trees, required-sections/RTA tables, and copy-paste usage commands ('python scripts/fda_submission_tracker.py /path/to/project --type 510k'), but several tables describe requirements rather than instruct, leaving minor gaps.	4 / 5
Workflow Clarity	The 510(k) workflow sequences phases with explicit per-phase 'Checkpoint:'/'Verification:' steps and CAPA includes verify/effectiveness steps; missing an explicit validate→fix→retry feedback loop keeps it just under a 5.	4 / 5
Progressive Disclosure	Clear overview with a TOC, each major section links to one-level-deep, real reference files ('See [qsr_compliance_requirements.md](references/...)'), and a Resources section lists all scripts/references for easy navigation.	5 / 5
	Total	17 / 20 Passed

Description

95%Weight 40%Scale 1-5

Based on the skill's description, can an agent find and select it at the right time? Clear, specific descriptions lead to better discovery.

A strong, well-structured description that clearly states the skill's purpose and provides comprehensive, natural trigger terms. Minor room to sharpen the action verbs beyond 'guidance/assessments' to lift specificity to a 5.

Dimension	Reasoning	Score
Specificity	Lists several concrete capabilities ('510(k)/PMA/De Novo pathway guidance, QMSR ... compliance, HIPAA assessments, and device cybersecurity') with minor gaps in crisp action verbs; not quite the exhaustive multi-action list of a 5.	4 / 5
Completeness	Explicitly answers both what ('FDA regulatory consultant ... Provides ... guidance, compliance, assessments, and cybersecurity') and when ('Use when user mentions FDA submission, 510(k), ...') with concrete trigger phrases.	5 / 5
Trigger Term Quality	Comprehensive natural-term coverage including synonyms and shorthand ('FDA submission, 510(k), PMA, De Novo, QMSR, QSR, ISO 13485 for FDA, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity') that users would naturally say.	5 / 5
Distinctiveness Conflict Risk	Clear FDA medical-device regulatory niche with distinct, specific triggers and minimal overlap risk with other skills.	5 / 5
	Total	19 / 20 Passed

Validation

100%

Warnings & errors only

Checks the skill against the spec for correct structure and formatting. All validation checks must pass before discovery and implementation can be scored.

Validation — 16 / 16 Passed

Validation for skill structure

No warnings or errors.

Repository: alirezarezvani/claude-skills
Path: ra-qm-team/skills/fda-consultant-specialist/SKILL.md
Commit: 19392f7

Reviewed: ~2 hours ago

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