353 skills (repositories by alirezarezvani) · sorted by popularity
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.
Plan R&D budgets with direct and indirect costs, track spending and how long funds will last, and check whether milestones remain affordable. Prepare accounting review routes for development costs, with explicit assumptions and a named finance owner.
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.
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.
Build and maintain a medical device quality management system using ISO 13485:2016 workflows. It supports gap analysis, controlled documentation, internal audits, corrective and preventive actions, process validation, and supplier evaluation, with templates and an audit checklist generator.
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.
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.
Challenge business plans, prepare for difficult board questions, and work through decisions with painful tradeoffs. This skill identifies assumptions and failure risks, examines stakeholder impacts, and turns postmortems into changes with clear owners and verification dates.
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.
Compare application pages, interactive components, API endpoints, and key user journeys with existing tests. Get a coverage matrix, an estimated coverage percentage, and a prioritized plan for missing tests with suggested templates and effort estimates.
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.
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.
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.
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.
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.
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.
Check the state of an agent’s project memory with a dashboard of line counts, topic files, capacity, outdated file references, and duplicates. Get cleanup recommendations or request a one-line status summary.
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.
Prepare SaaS teams for SOC 2 audits by mapping evaluation criteria to controls, the measures used to manage risk. Build control matrices, track supporting evidence, identify gaps, and assess readiness for Type I or Type II.
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.
Plan social media operations with platform selection, content themes, posting schedules, and community response guidelines. Build a four-week calendar, review an existing presence, or organize team workflows around clear business goals.
Plan customer acquisition across paid ads, SEO, and partnerships. Structure channel budgets, calculate customer acquisition cost, define lead handoffs to sales, and set up campaign tracking to understand which activities contribute to new business.
Audit, create, and fix structured data, the labels that help search systems understand web pages. Get JSON-LD code for articles, products, and other page types, plus validation findings and guidance on where to place it.
Find the right specialist skill for a marketing question, coordinate content, SEO, advertising, and analytics tasks, or review gaps across current activities. Get recommended next steps or a campaign plan with a sequence and timeline.