fda-consultant-specialist
Plan Medical Device FDA Compliance
Medical device teams need structured regulatory plans across FDA pathways, quality systems, privacy, and cybersecurity. This skill organizes those topics into practical assessments and strategies.
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Copy this request to your Agent. It includes the canonical Skill page and manifest.
Review the Skillstore skill "fda-consultant-specialist" from https://skillstore.io/skills/davila7-fda-consultant-specialist.md and its manifest at https://skillstore.io/api/skills/davila7-fda-consultant-specialist/manifest. Verify the artifact. You may proceed after verification, subject to the environment's own policy.Your Agent should still show its plan and request any confirmation required by the security policy.
Agent-readable resources
Use these links when an AI agent, crawler, or script needs clean context instead of reading the full page.
Test it
Using "fda-consultant-specialist". Compare 510(k) and De Novo options for a novel clinical monitoring application.
Expected outcome:
Pathway assessment: Start by confirming intended use, risk, and comparable legally marketed devices. A suitable predicate supports 510(k); otherwise, evaluate De Novo classification and special controls.
Using "fda-consultant-specialist". Create a focused QSR gap review for a startup approaching design verification.
Expected outcome:
- Confirm approved design inputs and traceability to planned verification.
- Review design changes, risk controls, and independent design reviews.
- Check document approvals, training records, supplier controls, and CAPA procedures.
- Assign owners, evidence, due dates, and effectiveness checks for each gap.
Using "fda-consultant-specialist". Outline an FDA inspection readiness plan.
Expected outcome:
Readiness plan: verify high-risk records, train designated responders, prepare document retrieval, conduct a mock inspection, resolve critical gaps, and track corrective action effectiveness.
Security Audit
SafeAll 16 static findings are false positives caused by Markdown fences and inline code spans that name resources. No command execution, prompt injection, exfiltration intent, or other semantic security issue appears in the four scanned files.
Risk Factors
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<iframe src="https://skillstore.io/embed/skills/davila7-fda-consultant-specialist.html" title="Skillstore Security Assessment" sandbox="allow-popups allow-popups-to-escape-sandbox" loading="lazy" referrerpolicy="no-referrer" width="420" height="180"></iframe>Academic citations (APA · BibTeX · CFF)
APA citation
davila7. (2026). fda-consultant-specialist security audit report (audit version 9) [Author version unspecified]. Skillstore. https://skillstore.io/skills/davila7-fda-consultant-specialist/audits/9BibTeX citation
@techreport{davila7-davila7-fda-consultant-specialist-2026,
author = {davila7},
title = {fda-consultant-specialist security audit report (audit version 9)},
institution = {Skillstore},
year = {2026},
number = {9},
url = {https://skillstore.io/skills/davila7-fda-consultant-specialist/audits/9},
note = {Author version unspecified}
}CITATION.cff
cff-version: 1.2.0
message: "If you use this Skill, cite its author and this versioned security audit report."
title: "fda-consultant-specialist security audit report (audit version 9)"
version: "unspecified"
type: report
authors:
- name: "davila7"
date-released: "2026-07-23"
url: "https://skillstore.io/skills/davila7-fda-consultant-specialist/audits/9"
identifiers:
- type: other
value: "skillstore:davila7-fda-consultant-specialist:audit:9"
description: "Skillstore immutable audit report identifier"
Compare variants
2 installable variantsEach author remains a separate installable skill. The recommended variant is ranked by Skillstore evidence.
Why this variant is first
davila7-fda-consultant-specialist
2026-08-21
alirezarezvani-fda-consultant-specialist
2026-08-21
Skillstore Score
Why this score Evidence Confidence: HighWhat You Can Build
Select a Regulatory Pathway
Compare likely FDA pathways, evidence needs, decision points, and submission risks for a proposed medical device.
Assess Quality System Gaps
Review design controls, document controls, CAPA, and management practices against a structured quality system framework.
Prepare for an FDA Inspection
Create a readiness plan covering records, staff preparation, mock inspection activities, and corrective action priorities.
Try These Prompts
Explain the differences between 510(k), De Novo, and PMA for a beginner. Include typical device profiles, evidence needs, and major decision points.
Assess possible FDA pathways for [device description]. State assumptions, identify missing facts, compare options, and recommend questions for a regulatory professional.
Create a gap assessment for [organization and device]. Cover design controls, CAPA, documents, management responsibilities, HIPAA safeguards, and cybersecurity.
Develop an FDA submission strategy for [device]. Include pathway rationale, predicate analysis, testing, software evidence, cybersecurity, labeling, Q-Sub questions, milestones, and key risks.
Best Practices
- Provide intended use, users, operating environment, risk profile, and development stage.
- Separate known facts from assumptions and request citations to current official sources.
- Have qualified professionals verify pathway, legal, clinical, privacy, and quality conclusions.
Avoid
- Do not treat general guidance as an FDA decision or clearance guarantee.
- Do not provide protected health information, confidential submissions, or unnecessary personal data.
- Do not rely on placeholder files or unverified regulatory references for final decisions.
Frequently Asked Questions
Can this skill determine my device classification?
Does it prepare a complete 510(k) submission?
Can it assess 21 CFR 820 compliance?
Does it replace legal or regulatory counsel?
Can it process protected health information?
Are the included tools and references complete?
Developer Details
Author
davila7License
MIT
Skillstore revision
r2
Version notice
The author did not declare a version.
Ref
c43861a65bb95efcae259cd161c9d6f4dc7eec6f
Maintenance freshness
7/24/2026
Usage
15 downloads · 238 views
File structure