Planning, sales, accounting, legal, and project management (4K skills)
Prepare internal audit materials for ISO/IEC 42001:2023, the AI management system standard. Identify gaps, link AI risks to controls, and build a 12-month audit plan with coverage priorities and auditor independence checks.
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.
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.
Examine a plan by imagining it has failed twelve months later. Identify weak assumptions, linked dependencies, and commitments that are hard to reverse, then outline validation steps and criteria for continuing, changing direction, or stopping.
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.
Organize EU AI Act compliance work with references to Articles and Annexes. Classify AI systems by risk, plan conformity assessments that check regulatory requirements, prepare technical documentation checklists, and map obligations and deadlines to organizational roles.
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.
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 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.
Work through difficult business decisions such as layoffs, product closures, or changes in company direction. Compare immediate and long-term consequences, map who is affected, and prepare a clear explanation and communication plan.
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.
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.
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.
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.
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.
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.
Create roadmap updates, release notes, and feature announcements tailored to executives, engineering teams, or customers. Choose a suitable roadmap format and generate changelogs from Git history, making progress, user value, dependencies, and next actions clear.
Design or review SaaS pricing by choosing what customers pay for, defining plan features, and assessing price points. Create pricing page outlines, customer research questions, and price increase plans with communication templates and risk scenarios.
Turn feature requests and customer interviews into product plans. Rank features with RICE, a scoring method for reach, impact, confidence, and effort, extract research findings, and draft requirements and roadmaps that reflect team capacity.
Manage complex software and SaaS projects by assessing schedules, budgets, quality, risks, and team capacity. Compare priorities across projects, identify resource constraints, and turn portfolio analysis into executive reports with recommendations for decisions and follow-up.
Route product questions to a specialist for prioritization, research, analytics, experiments, or implementation. Support recurring discovery by tracking interviews and assumption tests, checking how customer needs connect to proposed solutions, and returning results with a concise digest.
Manage Jira issues, build JQL searches, and design project workflows and reports. Use bundled scripts to generate search queries and check workflow designs, with guidance on which operations require Jira’s interface or API.
Build quarterly product plans by translating company goals into product and team OKRs, meaning objectives with measurable results. Generate linked goal hierarchies, check alignment across teams, and review how responsibilities are distributed.