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Supports medical device risk management from planning through post-market review using ISO 14971:2019. Helps identify hazards, evaluate risks, select and verify controls, assess remaining risks, and maintain records as new information arrives.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Create a medical device risk management plan
• Identify hazards and choose risk analysis methods
• Compare risk controls and assess remaining risks

Analyze failed launches, missed targets, or unsuccessful hires through a blameless review. Use five successive why questions to identify root causes, then record concrete changes with owners, deadlines, and ways to verify results.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Investigating why a release was delayed
• Reviewing a missed sales or revenue target
• Examining a hiring decision that did not work out

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

Help quality leaders at medical technology companies prepare management reviews, define quality objectives, and track performance indicators. Organize audit findings, complaints, corrective actions, and regulatory status into reports and assigned improvement actions.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Preparing quality management reviews
• Defining measurable quality objectives and indicators
• Tracking audit findings and corrective actions

Prepare medical device regulatory strategies and submission documents for FDA, EU, and other markets. Compare application routes, organize technical and clinical evidence, draft responses to regulator questions, and track submission schedules.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Comparing FDA application routes for a new medical device
• Organizing technical documentation for EU MDR
• Drafting responses to FDA or Notified Body questions

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

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

Run Playwright tests on BrowserStack to check behavior across browsers and devices. Configure cloud connections, compare results by browser, inspect session videos and logs, and set up a tunnel for testing local or restricted environments.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Checking browser compatibility with Playwright tests
• Configuring BrowserStack cloud test connections
• Investigating failures through session videos and logs

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

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

Review Claude Code’s automatically saved memory to identify outdated entries, duplicates, and conflicts with existing instructions. Produces a health report and recommendations for consolidating notes or turning recurring lessons into lasting project rules.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Reviewing lessons saved after a major development task
• Finding outdated or conflicting memory entries
• Identifying recurring lessons to turn into rules

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

Automate Google Workspace tasks with the gws command-line tool, including email, file management, spreadsheets, and scheduling. Get guidance on installation, authentication, reusable workflow templates, and security audits of sharing and account settings.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Automating Gmail sending and inbox organization
• Managing Drive files and sharing permissions
• Reading and updating Sheets data

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

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

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

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

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

Draft and edit internal updates, newsletters, FAQs, and incident reports using the appropriate reference format. Turn supplied notes or information retrieved through connected tools into concise communications tailored to the audience and reporting period.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Drafting weekly progress, plans, and problems updates
• Creating company-wide newsletters
• Organizing frequently asked questions and answers

Coordinate project delivery by routing requests to eight specialist skills or running a verified delivery workflow. Use live Jira data for progress analysis and completion forecasts, with recorded evidence and checks before tasks are closed.

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• Analyze sprint progress and forecast completion ranges
• Produce project health reports from live Jira data
• Route Jira permission and configuration reviews

Create signed records for consequential agent actions such as deployments, deletions, and payments. Decide which actions need evidence, record the agent, action, target, and policy, then verify the resulting certificate offline to detect later changes.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Creating signed records for production deployments
• Preserving evidence of deletions and payments
• Recording access grants for later review

Turn a written app specification into a runnable starter project using the requested technology stack. Generate implemented features, tests, configuration files, and setup instructions, then check the project for common omissions.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Turning a requirements document into a starter project
• Creating a task API with FastAPI and SQLite
• Building a recipe-sharing website with Next.js