HIPAA Safe Harbor Coverage Audit
maziyarpanahi/openmed
Checks OpenMed de-identified clinical text against the 18 HIPAA Safe Harbor identifier categories and reports gaps and residual re-identification risk.
FDA regulatory consultant for medical device companies. An agent skill from alirezarezvani/claude-skills.
Install Fda Consultant Specialist
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a claude-codeProject install by default; add -g for ~/.claude/skills/.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialist --agent claude-codeProject scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .claude/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.
Claude Code skills documentation · loads skills from .claude/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .claude/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.Claude Code copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$skill-installer install https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialistType this inside Codex. $skill-installer <name> installs a curated skill from openai/skills. The installer writes to $CODEX_HOME/skills (default ~/.codex/skills). Restart Codex if the skill does not show up.
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a codexProject install goes to .agents/skills/; add -g for ~/.codex/skills/.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialist --agent codexProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .agents/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .agents/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.agents/skills/ instead of .agents/skills for a personal install.
Codex skills documentation · loads skills from .agents/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .agents/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.Codex copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a cursorProject install goes to .agents/skills/; add -g for ~/.cursor/skills/.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialist --agent cursorProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .cursor/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .cursor/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.cursor/skills/ instead of .cursor/skills for a personal install.
Cursor skills documentation · loads skills from .cursor/skills/, .agents/skills/, .claude/skills/, .codex/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .cursor/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.Cursor copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gemini skills install https://github.com/alirezarezvani/claude-skills.git --path ra-qm-team/skills/fda-consultant-specialist--scope user (default) or --scope workspace; --path is the subfolder of the repo that holds the skill; --consent skips the security confirmation prompt.
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a gemini-cliProject install goes to .agents/skills/; add -g for ~/.gemini/skills/.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialist --agent gemini-cliProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .gemini/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .gemini/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.gemini/skills/ instead of .gemini/skills for a personal install, then run /skills reload.
Gemini CLI skills documentation · loads skills from .gemini/skills/, .agents/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .gemini/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.Gemini CLI copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialistInstalls for Copilot at project scope by default; add --scope user for a personal install. Preview a skill first with gh skill preview. Needs GitHub CLI 2.90.0 or later (public preview).
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a github-copilotProject install goes to .agents/skills/; add -g for ~/.copilot/skills/.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .github/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .github/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.copilot/skills/ instead of .github/skills for a personal install. Commit .github/skills so cloud agent and code review can use it.
GitHub Copilot skills documentation · loads skills from .github/skills/, .claude/skills/, .agents/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .github/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.GitHub Copilot copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
$ npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a opencodeOpenCode documents no install command of its own. Project install goes to .agents/skills/; add -g for ~/.config/opencode/skills/.
$ gh skill install alirezarezvani/claude-skills fda-consultant-specialist --agent opencodeProject scope by default (.agents/skills/); add --scope user for a personal install.
$ git clone --depth 1 https://github.com/alirezarezvani/claude-skills.git skills-src && mkdir -p .opencode/skills && cp -r skills-src/ra-qm-team/skills/fda-consultant-specialist .opencode/skills/fda-consultant-specialist && rm -rf skills-srcUse ~/.config/opencode/skills/ instead of .opencode/skills for a personal install.
OpenCode skills documentation · loads skills from .opencode/skills/, .claude/skills/, .agents/skills/
Install the "fda-consultant-specialist" agent skill from https://github.com/alirezarezvani/claude-skills/tree/main/ra-qm-team/skills/fda-consultant-specialist into .opencode/skills/fda-consultant-specialist/ in this project. Copy the whole folder (SKILL.md and every file beside it), keep the folder name "fda-consultant-specialist", then confirm the skill loads.OpenCode copies the folder itself, the same result as the manual copy. Check what it changed before you commit it.
Facts
- Skill name
fda-consultant-specialist- GitHub stars
- 28k
- Token cost
- ~2.9k tokens
- SKILL.md length
- 893 words
- Files
- 9 (incl. scripts, references)
- Skills in repo
- 342
- Repo updated
- First seen
- Licence
- MIT
At a glance
FDA regulatory consultant for medical device companies. An agent skill from alirezarezvani/claude-skills.
- Works in 5 steps: Identify product code and classification → Search 510(k) database for predicates → Assess substantial equivalence feasibility → …
- User mentions FDA submission
- SKILL.md covers Table of Contents, FDA Pathway Selection, 510(k) Submission Process and QMSR Compliance (formerly QSR), plus 3 more sections
- Runs Python scripts from its folder; calls python
What it does
Fda Consultant Specialist is an agent skill from alirezarezvani/claude-skills. 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.
Its SKILL.md is about 2.9k tokens, which your agent loads only when the skill is triggered. The skill folder holds 10 other files, including scripts and reference files (for example `references/device_cybersecurity_guidance.md`, `references/fda_capa_requirements.md` and `references/fda_submission_guide.md`).
It sits in Legal & Compliance, covering Healthcare and finance regulation. The repository describes itself as: 380 Claude Code skills & agent skills & plugins (30+ Agents, 70+ custom commands, 380+ skills, customizable references, scripts)for Claude Code, Codex, Gemini CLI, Cursor, and 8… The licence is MIT.
When your agent uses it
- User mentions FDA submission
- ISO 13485 for FDA
- Predicate device
- Substantial equivalence
Example prompts
- “/fda-consultant-specialist”
Requirements
- Python 3
Workflow steps
5 steps, taken from the first numbered list in SKILL.md.
- Identify product code and classification
- Search 510(k) database for predicates
- Assess substantial equivalence feasibility
- Prepare Q-Sub questions for FDA
- Schedule Pre-Sub meeting if needed
What it can do on your machine
Read from SKILL.md and the folder at commit 19392f7. It shows what the files ask for, not the result of running them.
Tool permissions
Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.
From allowed-tools in the SKILL.md frontmatter.
Runs code
Ships 3 files in scripts/ (Python), which the agent can run.
Shell commands in SKILL.md call:
python
From the folder's file list and the shell code blocks in SKILL.md.
Network
No URLs in SKILL.md.
From URLs in SKILL.md, links to its own repository left out.
Credentials
Names no API keys, tokens, secrets or passwords.
From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.
Context cost
Fda Consultant Specialist loads about 2.9k tokens when it runs, and up to ~26k if it reads all its reference files. Until then it costs about 118 tokens; SKILL.md has 893 words of instructions outside code blocks.
Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.
Safety
Auto-check passed
The automated check found no risky patterns in SKILL.md.
Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.
SKILL.md
The full file from alirezarezvani/claude-skills at commit 19392f7, republished under its MIT licence (© alirezarezvani). 893 words, ~2,945 tokens.
Download SKILL.mdSave it as
.claude/skills/fda-consultant-specialist/SKILL.md (or your agent's skills folder). This skill also uses 8 other files; get the full folder from GitHub.- name
- fda-consultant-specialist
- description
- 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.
FDA Consultant Specialist
FDA regulatory consulting for medical device manufacturers covering submission pathways, the Quality Management System Regulation (QMSR, 21 CFR Part 820 — formerly the QSR), HIPAA compliance, and device cybersecurity requirements.
Table of Contents
- FDA Pathway Selection
- 510(k) Submission Process
- QMSR Compliance (formerly QSR)
- HIPAA for Medical Devices
- Device Cybersecurity
- Resources
FDA Pathway Selection
Determine the appropriate FDA regulatory pathway based on device classification and predicate availability.
Decision Framework
Predicate device exists?
├── YES → Substantially equivalent?
│ ├── YES → 510(k) Pathway
│ │ ├── No design changes → Abbreviated 510(k)
│ │ ├── Manufacturing only → Special 510(k)
│ │ └── Design/performance → Traditional 510(k)
│ └── NO → PMA or De Novo
└── NO → Novel device?
├── Low-to-moderate risk → De Novo
└── High risk (Class III) → PMAPathway Comparison
| Pathway | When to Use | Timeline | User Fee (FY2024) |
|---|---|---|---|
| 510(k) Traditional | Predicate exists, design changes | 90 days | $21,760 (FY2024) |
| 510(k) Special | Manufacturing changes only | 30 days | $21,760 (FY2024) |
| 510(k) Abbreviated | Guidance/standard conformance | 30 days | $21,760 (FY2024) |
| De Novo | Novel, low-moderate risk | 150 days | $134,676 (FY2024) |
| PMA | Class III, no predicate | 180+ days | $425,000+ (FY2024) |
User fees are set annually under MDUFA. Verify current-fiscal-year fees at fda.gov (MDUFA user fee schedule) before budgeting; small-business rates differ.
Pre-Submission Strategy
- Identify product code and classification
- Search 510(k) database for predicates
- Assess substantial equivalence feasibility
- Prepare Q-Sub questions for FDA
- Schedule Pre-Sub meeting if needed
Reference: See fda_submission_guide.md for pathway decision matrices and submission requirements.
510(k) Submission Process
Workflow
Phase 1: Planning
├── Step 1: Identify predicate device(s)
├── Step 2: Compare intended use and technology
├── Step 3: Determine testing requirements
└── Checkpoint: SE argument feasible?
Phase 2: Preparation
├── Step 4: Complete performance testing
├── Step 5: Prepare device description
├── Step 6: Document SE comparison
├── Step 7: Finalize labeling
└── Checkpoint: All required sections complete?
Phase 3: Submission
├── Step 8: Assemble submission package
├── Step 9: Submit via eSTAR
├── Step 10: Track acknowledgment
└── Checkpoint: Submission accepted?
Phase 4: Review
├── Step 11: Monitor review status
├── Step 12: Respond to AI requests
├── Step 13: Receive decision
└── Verification: SE letter received?Required Sections (21 CFR 807.87)
| Section | Content |
|---|---|
| Cover Letter | Submission type, device ID, contact info |
| Form 3514 | CDRH premarket review cover sheet |
| Device Description | Physical description, principles of operation |
| Indications for Use | Form 3881, patient population, use environment |
| SE Comparison | Side-by-side comparison with predicate |
| Performance Testing | Bench, biocompatibility, electrical safety |
| Software Documentation | Level of concern, hazard analysis (IEC 62304) |
| Labeling | IFU, package labels, warnings |
| 510(k) Summary | Public summary of submission |
Common RTA Issues
| Issue | Prevention |
|---|---|
| Missing user fee | Verify payment before submission |
| Incomplete Form 3514 | Review all fields, ensure signature |
| No predicate identified | Confirm K-number in FDA database |
| Inadequate SE comparison | Address all technological characteristics |
QMSR Compliance (formerly QSR)
Quality Management System Regulation (QMSR) requirements for medical device manufacturers under 21 CFR Part 820.
QMSR transition (effective 2026-02-02): FDA's QMSR final rule (89 FR 7496) amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference and removed the legacy QSR subsection structure (820.20–820.198). Those subsection numbers are historical and no longer exist in the CFR; the corresponding requirements now flow from ISO 13485:2016 clauses plus the retained/renumbered sections 820.10 (requirements, incl. the ISO 13485 incorporation), 820.35 (records), and 820.45 (device labeling and packaging controls). 21 CFR Parts 801, 803, 806, and 830 are unchanged. Legacy QSR numbers below are kept only as a familiar index, each mapped to its current ISO 13485 clause.
Key Quality Subsystems (legacy QSR index → current ISO 13485:2016 clause)
| Legacy QSR Section (historical, pre-2026) | Title | Current authority under QMSR | Focus |
|---|---|---|---|
| 820.20 | Management Responsibility | ISO 13485 §5.1, 5.5, 5.6 | Quality policy, org structure, management review |
| 820.30 | Design Controls | ISO 13485 §7.3 | Input, output, review, verification, validation |
| 820.40 | Document Controls | ISO 13485 §4.2.4 | Approval, distribution, change control |
| 820.50 | Purchasing Controls | ISO 13485 §7.4 | Supplier qualification, purchasing data |
| 820.70 | Production Controls | ISO 13485 §6.3, 6.4, 7.5 | Process validation, environmental controls |
| 820.100 | CAPA | ISO 13485 §8.5.2, 8.5.3 | Root cause analysis, corrective actions |
| 820.181 | Device Master Record | ISO 13485 §4.2.3 (medical device file) + 21 CFR 820.35 | Specifications, procedures, acceptance criteria |
Design Controls Workflow (ISO 13485 §7.3; legacy QSR 820.30)
Step 1: Design Input
└── Capture user needs, intended use, regulatory requirements
Verification: Inputs reviewed and approved?
Step 2: Design Output
└── Create specifications, drawings, software architecture
Verification: Outputs traceable to inputs?
Step 3: Design Review
└── Conduct reviews at each phase milestone
Verification: Review records with signatures?
Step 4: Design Verification
└── Perform testing against specifications
Verification: All tests pass acceptance criteria?
Step 5: Design Validation
└── Confirm device meets user needs in actual use conditions
Verification: Validation report approved?
Step 6: Design Transfer
└── Release to production with DMR complete
Verification: Transfer checklist complete?Show full SKILL.md (363 more words)Show less
CAPA Process (ISO 13485 §8.5.2/8.5.3; legacy QSR 820.100)
- Identify: Document nonconformity or potential problem
- Investigate: Perform root cause analysis (5 Whys, Fishbone)
- Plan: Define corrective/preventive actions
- Implement: Execute actions, update documentation
- Verify: Confirm implementation complete
- Effectiveness: Monitor for recurrence (30-90 days)
- Close: Management approval and closure
Reference: See qsr_compliance_requirements.md for the historical QSR structure with full QMSR/ISO 13485:2016 clause mapping.
HIPAA for Medical Devices
HIPAA requirements for devices that create, store, transmit, or access Protected Health Information (PHI).
Applicability
| Device Type | HIPAA Applies |
|---|---|
| Standalone diagnostic (no data transmission) | No |
| Connected device transmitting patient data | Yes |
| Device with EHR integration | Yes |
| SaMD storing patient information | Yes |
| Wellness app (no diagnosis) | Only if stores PHI |
Required Safeguards
Administrative (§164.308)
├── Security officer designation
├── Risk analysis and management
├── Workforce training
├── Incident response procedures
└── Business associate agreements
Physical (§164.310)
├── Facility access controls
├── Workstation security
└── Device disposal procedures
Technical (§164.312)
├── Access control (unique IDs, auto-logoff)
├── Audit controls (logging)
├── Integrity controls (checksums, hashes)
├── Authentication (MFA recommended)
└── Transmission security (TLS 1.2+)Risk Assessment Steps
- Inventory all systems handling ePHI
- Document data flows (collection, storage, transmission)
- Identify threats and vulnerabilities
- Assess likelihood and impact
- Determine risk levels
- Implement controls
- Document residual risk
Reference: See hipaa_compliance_framework.md for implementation checklists and BAA templates.
Device Cybersecurity
FDA cybersecurity requirements for connected medical devices.
Premarket Requirements
| Element | Description |
|---|---|
| Threat Model | STRIDE analysis, attack trees, trust boundaries |
| Security Controls | Authentication, encryption, access control |
| SBOM | Software Bill of Materials (CycloneDX or SPDX) |
| Security Testing | Penetration testing, vulnerability scanning |
| Vulnerability Plan | Disclosure process, patch management |
Device Tier Classification
Tier 1 (Higher Risk):
- Connects to network/internet
- Cybersecurity incident could cause patient harm
Tier 2 (Standard Risk):
- All other connected devices
Postmarket Obligations
- Monitor NVD and ICS-CERT for vulnerabilities
- Assess applicability to device components
- Develop and test patches
- Communicate with customers
- Report to FDA per guidance
Coordinated Vulnerability Disclosure
Researcher Report
↓
Acknowledgment (48 hours)
↓
Initial Assessment (5 days)
↓
Fix Development
↓
Coordinated Public DisclosureReference: See device_cybersecurity_guidance.md for SBOM format examples and threat modeling templates.
Resources
scripts/
| Script | Purpose |
|---|---|
fda_submission_tracker.py | Track 510(k)/PMA/De Novo submission milestones and timelines |
qsr_compliance_checker.py | Assess QMS documentation against the legacy-QSR checklist mapped to ISO 13485:2016 (QMSR) |
hipaa_risk_assessment.py | Evaluate HIPAA safeguards in medical device software |
references/
| File | Content |
|---|---|
fda_submission_guide.md | 510(k), De Novo, PMA submission requirements and checklists |
qsr_compliance_requirements.md | Historical QSR structure with QMSR/ISO 13485:2016 mapping, implementation templates |
hipaa_compliance_framework.md | HIPAA Security Rule safeguards and BAA requirements |
device_cybersecurity_guidance.md | FDA cybersecurity requirements, SBOM, threat modeling |
fda_capa_requirements.md | CAPA process, root cause analysis, effectiveness verification |
Usage Examples
# Track FDA submission status
python scripts/fda_submission_tracker.py /path/to/project --type 510k
# Assess QMS documentation (legacy QSR section keys, mapped to ISO 13485 under QMSR)
python scripts/qsr_compliance_checker.py /path/to/project --section 820.30 # legacy checklist key = ISO 13485 §7.3 (design & development)
# Run HIPAA risk assessment
python scripts/hipaa_risk_assessment.py /path/to/project --category technical© alirezarezvani, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file
Files
SKILL.md and 8 other files (scripts, references) in ra-qm-team/skills/fda-consultant-specialist of alirezarezvani/claude-skills.
- SKILL.md
- references/device_cybersecurity_guidance.md
- references/fda_capa_requirements.md
- references/fda_submission_guide.md
- references/hipaa_compliance_framework.md
- references/qsr_compliance_requirements.md
- scripts/fda_submission_tracker.py
- scripts/hipaa_risk_assessment.py
- scripts/qsr_compliance_checker.py
Open the folder on GitHubat commit 19392f7
Compare with similar skills
Fda Consultant Specialist next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.
| Skill | Stars | Used in | Tokens | Auto-check | Licence | Repo updated |
|---|---|---|---|---|---|---|
| Fda Consultant Specialist this skillalirezarezvani/claude-skills | 28k | — | ~2.9k | Automated safety check: Pass | MIT | |
| HIPAA Safe Harbor Coverage Auditmaziyarpanahi/openmed | 5.5k | — | ~1.7k | Automated safety check: Pass | Apache-2.0 | |
| HIPAA Pre-Deployment Compliance Checkmaziyarpanahi/openmed | 5.5k | — | ~2k | Automated safety check: Pass | Apache-2.0 | |
| Hipaa ComplianceSushegaad/Claude-Skills-Governance-Risk-and-Compliance | 946 | 1 repos | ~2.3k | Automated safety check: Pass | MIT | |
| ISO Standards Readiness EvidenceK-Dense-AI/scientific-agent-skills | 48k | 1 repos | ~4.6k | Automated safety check: Notes | MIT | |
| Fda Consultant Specialistdavila7/claude-code-templates | 33k | 1 repos | ~2.7k | Automated safety check: Pass | MIT |
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Reverse-engineers a frontend, backend or fullstack codebase into a product requirements document with per-page docs, an enum dictionary and an API inventory.
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Questions about Fda Consultant Specialist
What does Fda Consultant Specialist do?
FDA regulatory consultant for medical device companies. An agent skill from alirezarezvani/claude-skills. Fda Consultant Specialist is an agent skill from alirezarezvani/claude-skills. FDA regulatory consultant for medical device companies.
When should I use Fda Consultant Specialist?
Fda Consultant Specialist fits situations like: user mentions FDA submission; ISO 13485 for FDA; predicate device; substantial equivalence.
How do I install Fda Consultant Specialist in Claude Code?
Run `npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a claude-code`. Or copy the skill folder (ra-qm-team/skills/fda-consultant-specialist in alirezarezvani/claude-skills) into .claude/skills/fda-consultant-specialist in your project. Claude Code loads it when a task matches its description.
How do I install Fda Consultant Specialist in Codex?
Run `npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a codex`. Or copy the skill folder (ra-qm-team/skills/fda-consultant-specialist in alirezarezvani/claude-skills) into .agents/skills/fda-consultant-specialist in your project. Codex loads it when a task matches its description.
Can I use Fda Consultant Specialist in Cursor, Gemini CLI or GitHub Copilot?
Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add alirezarezvani/claude-skills --skill fda-consultant-specialist -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/fda-consultant-specialist, .gemini/skills/fda-consultant-specialist, .github/skills/fda-consultant-specialist and .opencode/skills/fda-consultant-specialist in your project.
What does Fda Consultant Specialist need to run?
Going by SKILL.md and its folder, Fda Consultant Specialist needs Python for the scripts in its folder and the command-line tools its instructions call (python). Our summary lists: Python 3.
Does Fda Consultant Specialist access the network?
SKILL.md contains no URLs. Any network use would come from the scripts or tools the agent runs. This is read from the text; nothing was executed.
Is Fda Consultant Specialist safe to install?
Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.
What licence does Fda Consultant Specialist use?
Fda Consultant Specialist is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.
How many tokens does Fda Consultant Specialist use?
About 2.9k tokens (SKILL.md is roughly 12k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 23k tokens, read only when the agent opens those files.
What are the alternatives to Fda Consultant Specialist?
Skills that share tags, products or a category with Fda Consultant Specialist: HIPAA Safe Harbor Coverage Audit (maziyarpanahi/openmed, 5.5k stars), HIPAA Pre-Deployment Compliance Check (maziyarpanahi/openmed, 5.5k stars), Hipaa Compliance (Sushegaad/Claude-Skills-Governance-Risk-and-Compliance, 946 stars) and ISO Standards Readiness Evidence (K-Dense-AI/scientific-agent-skills, 48k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.
Who maintains Fda Consultant Specialist?
alirezarezvani (a GitHub user) maintains it in alirezarezvani/claude-skills, which has 27,938 GitHub stars. The repository holds 342 skills in this directory. The repository was last updated on August 30, 2026.
Source: alirezarezvani/claude-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.