비즈니스 스킬

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Reviewing a plan before committing major resources
• Checking assumptions before a board or investor presentation
• Examining plans that receive only positive feedback

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 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

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

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

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Weighing layoffs and their impact on the team
• Comparing options for closing a product line
• Considering a co-founder's role change or departure

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

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Planning a medical device quality management system
• Standardizing document approval and revision control
• Preparing internal audits and certification reviews

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

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Find weaknesses in a business plan
• Prepare answers to difficult board questions
• Compare options for a difficult management decision

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Build an R&D budget with an explicit indirect-cost split
• Check whether remaining funds cover the next milestone
• Prepare development costs for accounting review

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Prioritizing gaps before certification
• Linking AI risks to Annex A controls
• Planning a year of internal audits

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

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

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

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

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Reviewing risk classification for a new AI system
• Planning conformity assessments for high-risk AI
• Preparing technical documentation checklists

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Drafting quarterly product goals
• Translating company goals into team OKRs
• Reviewing conflicts and gaps between team goals

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Ranking feature requests within team capacity
• Finding shared pain points across customer interviews
• Drafting product requirements with success metrics

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Review progress and health across multiple projects
• Assess risks and prioritize response actions
• Rebalance staffing based on team capacity

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Finding overdue or stale Jira issues
• Creating issues and updating their status
• Checking workflow designs for unreachable states

Analyze sprint history to forecast delivery ranges, score team health, and track retrospective actions. Python tools turn structured sprint data into reports that support planning, highlight recurring problems, and show whether improvement efforts are progressing.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Forecasting sprint workload from past delivery data
• Assessing team health and prioritizing improvements
• Tracking retrospective actions and recurring themes

Evaluate product ideas before committing development resources. Organize customer needs, rank uncertain assumptions, and plan interviews or prototype tests in a short discovery cycle that ends with evidence for proceeding, changing direction, or stopping.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Mapping customer needs to solution ideas and experiments
• Prioritizing risky assumptions for testing
• Planning customer interviews and prototype tests

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.

한국어 요약은 준비 중입니다. 영어 요약을 표시하고 있습니다.

• Designing pricing plans for a new SaaS product
• Reviewing existing prices and plan features
• Planning a price increase and customer notices