Skill UI

Guides medical device teams through EU MDR 2017/745 classification, technical documentation, clinical evidence, and post-market surveillance workflows, covering Annex VIII/II/III/XIV, MDCG software rules, EUDAMED and UDI integration, and notified body validation checkpoints.

This system implements Role-Based Access Control (RBAC) for OpenEvidence, an AI-powered clinical decision support platform. It strictly manages access to sensitive data, including PHI-adjacent datasets and medical literature, ensuring compliance with regulations like HIPAA. The system defines distinct roles—Admin, Clinician, Researcher, Student, and Auditor—with granular permissions for querying, data export, and institutional configuration, maintaining a secure and auditable data environment.

This tool analyzes and compares staking opportunities across various Proof-of-Stake (PoS) blockchains and liquid staking protocols. It calculates net Annual Percentage Yield (APY), assesses protocol risks, and provides data-driven recommendations for optimal asset allocations to maximize returns while managing risk. Use it when analyzing staking opportunities, comparing validators, or optimizing your DeFi portfolio.

This comprehensive skill helps establish and maintain a foundational 'Product Marketing Context' document. It serves as a single source of truth, capturing critical details like Ideal Customer Profile (ICP), core pain points, competitive landscape, and brand voice. Use this skill at the start of any new project to ensure consistent, deep, and accurate marketing messaging across all downstream tasks.

A comprehensive toolkit designed for Product Heads to define, cascade, and align Objectives and Key Results (OKRs) across the entire organization. This tool supports quarterly strategic planning, allowing users to define company-wide goals, decompose them into product objectives, and further cascade them to specific team goals. It measures critical alignment scores (vertical, horizontal) and generates structured roadmaps for maximizing organizational excellence and strategic focus.

Guides ISO 13485 internal audits for medical device QMS, covering risk-based planning, execution, finding classification, CAPA verification, and readiness for external reviewers.

Implements and maintains ISO 13485 QMS for medical device organizations, covering gap analysis, documentation control, internal audits, supplier qualification, and CAPA tracking to keep regulatory programs audit-ready.

Provides senior regulatory affairs guidance for HealthTech and MedTech firms, driving FDA 510(k)/De Novo/PMA submissions, CE marking, and multi-market access strategies while maintaining intelligence on evolving regulations.

This skill guides the configuration of Speak for enterprise environments, such as schools and large organizations. It covers implementing Role-Based Access Control (RBAC), setting up Single Sign-On (SSO), managing diverse roles (teacher/student), handling class management, and establishing usage reporting. This setup is essential for deploying a secure, scalable language learning platform tailored for institutional use.

This expert skill acts as a dedicated business analyst for early-stage companies (pre-seed to Series A). It provides comprehensive, actionable analysis covering market sizing (TAM/SAM/SOM), rigorous financial modeling (LTV, CAC, cash flow), competitive strategy, and organizational planning. Use it to develop investor-ready reports and guide critical strategic decisions for founders and entrepreneurs.

Build comprehensive 3-5 year financial models essential for startup planning and fundraising. This skill meticulously projects revenue using cohort-based methods, details cost structures (COGS, S&M, R&D, G&A), plans headcount, and performs detailed cash flow analysis. It calculates critical metrics like LTV, CAC, and burn rate, providing three scenarios (conservative, base, optimistic) for robust strategic decision-making.

This skill guides users through a comprehensive, structured process for calculating and analyzing market opportunities for startups. It provides detailed methodologies, including bottom-up and top-down market sizing, to determine the Total Addressable Market (TAM), Serviceable Available Market (SAM), and Serviceable Obtainable Market (SOM). Use this when developing business plans, conducting feasibility studies, or assessing market potential for a new product or service.