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Explicitly save debugging discoveries, project conventions, and working preferences to Claude's persistent project memory. The skill checks for duplicate notes, keeps entries concise, and suggests moving enforceable rules into CLAUDE.md when appropriate.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Preserving hard-won debugging discoveries
• Recording undocumented project conventions
• Remembering tool-specific commands and pitfalls

Supports medical device quality investigations through CAPA, a process for corrective and preventive action. Helps identify root causes, plan actions, verify results, and report overdue cases, recurrence rates, and other program metrics.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Investigating recurring quality problems
• Planning corrective actions after audit findings
• Checking whether corrective actions prevented recurrence

Prepare medical device regulatory work for the US FDA. Compare submission routes, organize required documents, review quality management requirements, assess patient data safeguards under HIPAA, and plan device cybersecurity documentation and controls.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Compare 510(k), PMA, and De Novo submission routes
• Organize required 510(k) documents and submission milestones
• Review quality documentation against QMSR and ISO 13485:2016

Set up Playwright, a browser testing tool, for an existing web project. Generate configuration, test folders, an example test, and applicable CI automation, then run the test and address setup failures.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Adding browser tests to an existing web project
• Configuring tests for the project's framework
• Running browser tests automatically in CI

Move browser tests from Cypress or Selenium to Playwright with file-by-file conversion and verification. The skill also adapts shared helpers and element selectors, updates CI workflows and documentation, and reports tests that need manual work.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Migrate a Cypress test suite
• Convert Selenium tests to Playwright
• Try migration on a single test file

Examine business assumptions behind revenue forecasts, market estimates, or hiring plans. Identify counter-evidence, model worse outcomes, assess how changes affect results, and propose validation steps, backup plans, and early warning indicators.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Testing the assumptions behind a revenue forecast
• Checking market size estimates against target customer counts
• Assessing how hiring delays would affect a plan

Support information security management for healthcare and medical technology companies. Structure an ISO 27001 management system, assess risks, review security controls, and prepare audit evidence, gap reports, and incident response procedures.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Planning an information security management system
• Assessing risks to patient data and medical devices
• Finding gaps in security control implementation

Review code for privacy risks, prepare data protection impact assessments, and track personal data requests and deadlines. The skill supports GDPR and German privacy compliance work, with final compliance decisions referred to a data protection officer or legal counsel.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Checking a service's code for privacy risks
• Preparing a data protection impact assessment
• Tracking deadlines for access and erasure requests

Turn recurring lessons in Claude's automatic memory into concise project rules. Choose a project-wide, file-specific, or personal rule location, include concrete commands, and clean up the original memory entry after confirmation.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Make repeated corrections into lasting rules
• Record the project's package manager
• Apply API rules to selected file paths

Summarize Playwright test results in a Markdown report with failures, timings, and tests that pass only after retries. Use configured reporting destinations and compare earlier reports when historical results are available.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Summarizing the latest Playwright test run
• Reviewing failed tests and their error messages
• Sharing results through configured Slack or TestRail connections

Organize document control for medical device quality management, including numbering, revisions, approvals, and change workflows. Includes guidance on electronic records and signatures, plus a Python validator for document metadata and completeness checks.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Defining document numbering and revision rules
• Designing review and approval workflows
• Organizing document changes and impact assessments

Supports preparation for EU medical device regulation reviews by organizing device classification, technical documentation, clinical evidence, and post-market monitoring. Includes a tool to identify documentation and compliance gaps and prioritize the next steps.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Documenting a device classification rationale under MDR
• Checking technical documentation before a review
• Planning clinical evaluation and identifying evidence gaps

Build market research evidence by comparing two market-size estimates, calculating survey sample sizes for each customer group, and scoring potential segments. Outputs show methods and assumptions so teams can assess the basis for business decisions.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Estimating market size for a business decision
• Planning survey responses for each customer segment
• Evaluating which market segments to pursue

Set up Playwright browser tests, generate cases from specifications or URLs, and review coverage gaps. Diagnose tests that fail inconsistently, migrate Cypress or Selenium suites, and optionally connect TestRail and BrowserStack for results and browser testing.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Set up Playwright tests and CI
• Generate and review tests from user stories
• Diagnose tests that fail inconsistently

Create Playwright tests from a user story, page URL, component path, or feature description. The skill follows existing project conventions, covers expected behavior and error cases, creates supporting files when needed, and runs the tests to check results.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Adding tests for login behavior
• Testing checkout and form submission flows
• Checking search filters and component interactions

Plan ISO 27001 information security audits, review evidence that security controls work, and document findings. The skill also helps classify failures, track corrective actions, and prepare documentation for certification audits.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Planning an annual internal audit
• Reviewing evidence for Annex A controls
• Documenting findings and corrective actions

Prepare for board meetings, investor updates, and fundraising presentations by reviewing key numbers, rehearsing difficult questions, and shaping an honest business narrative. Includes preparation for individual directors and follow-up actions after the meeting.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Rehearsing difficult questions before a board meeting
• Preparing key metrics for an investor update
• Explaining missed targets and corrective actions

Route enterprise research questions to specialized skills for clinical studies, R&D finance, market research, or user research. Receive a concise digest of findings, next actions, output files, and assumptions that need human review.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Plan a clinical study and sample size
• Review R&D budgets and spending classifications
• Estimate market size and design surveys

Connect TestRail test cases with Playwright automated tests. Generate tests from documented steps, send execution results back, create test runs, and check which cases remain unlinked using case IDs recorded in each test.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Generating Playwright tests from TestRail cases
• Sending automated test results to TestRail
• Creating a test run for regression testing

Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Choosing a skill for ISO 13485 audit preparation
• Routing questions about EU AI Act risk classification
• Finding the right workflow for GDPR requests

Plan user research by matching methods to study goals and explaining participant numbers and confidence. Synthesize tagged observations into recurring findings, distinguish isolated anecdotes, and organize evidence so research results can be found and reused.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Choose a research method for a study goal
• Explain participant numbers and confidence
• Find recurring patterns across participants

Diagnose failing or intermittent Playwright tests by reproducing errors and examining execution traces. Classify the cause, apply a targeted fix, and run the test ten times to check stability, with recommendations to prevent recurrence.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Fixing a Playwright test that fails consistently
• Investigating tests that pass only sometimes
• Debugging failures limited to CI

Plan a prospective clinical study by ranking endpoints, estimating participant numbers and statistical power, and assessing feasibility. Outputs include assumptions and named reviewers, providing material for expert review before a protocol is finalized.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Choosing primary and secondary study endpoints
• Estimating sample size with dropout allowance
• Assessing feasibility before a study review

Plan and conduct internal audits for medical device quality management systems under ISO 13485. Organize evidence, classify findings, verify corrective and preventive actions, and prepare for external audits with structured checklists and risk-based scheduling.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Plan an annual internal audit schedule
• Document audit evidence and classify findings
• Verify the effectiveness of corrective actions