Skill UI

A comprehensive guide for achieving compliance with the EU MDR 2017/745. It covers crucial aspects including medical device classification (Annex VIII), developing technical documentation (Annex II/III), planning clinical evaluation (CER), and establishing post-market surveillance (PMS/PSUR) systems. Ideal for regulatory specialists preparing for Notified Body audits or needing to gap-check technical files.

Streamline Microsoft Clarity analytics exports inside Claude Code via the Composio integration, fetching heatmaps, session metrics, and engagement data segmented by browser, device, location, source, medium, campaign, channel, or URL over the last 1-3 days.

Guides adding PyTorch FSDP2’s fully_shard integration to training loops, covering correct distributed init, bottom-up sharding, mixed precision/offload policies, DTensor-aware optimizers, and distributed checkpointing so oversized models or DeviceMesh sharding goals work reliably.

PyTorch Lightning is a high-level framework built on PyTorch that significantly reduces boilerplate code in deep learning training loops. It automatically handles device management, distributed training (DDP, FSDP, DeepSpeed), mixed precision, and advanced callbacks. It allows researchers to scale models from local machines to supercomputers with minimal code changes, enabling clean, scalable, and best-practice deep learning implementations.

This comprehensive guide provides expertise in conducting ISO 13485 internal audits for medical device Quality Management Systems (QMS). It covers the full audit lifecycle, including risk-based planning, systematic evidence collection, classifying nonconformities (Major/Minor), and managing CAPA verification to ensure regulatory compliance and continuous improvement.

A comprehensive guide for designing and managing document control systems for ISO 13485-compliant Quality Management Systems (QMS), specifically tailored for the medical device industry. This resource covers document numbering, version control, change management workflows, approval processes, and ensures compliance with rigorous standards like 21 CFR Part 11, including electronic signatures and audit trails.

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.

A comprehensive guide for implementing ISO 14971:2019 risk management across the entire medical device lifecycle. Covers planning, hazard identification, risk analysis (FMEA, FTA), risk evaluation, risk control, and post-market surveillance. Essential for achieving regulatory compliance in medical device development.

This skill validates web applications across diverse browsers (Chromium, Gecko, WebKit) and real mobile devices. It supports both local testing using Playwright and scalable cloud testing via major platforms like BrowserStack, Sauce Labs, and Kobiton. Use it when ensuring consistent UI/UX, correct CSS rendering, and functional JavaScript behavior regardless of the target environment or device type.

This skill outlines security best practices for the TwinMind AI meeting assistant. It covers crucial aspects like on-device audio processing, encrypted cloud backups, and managing microphone permissions. Use it when setting up new TwinMind instances or managing AI operations to ensure data privacy, compliance, and robust security for sensitive meeting data.

Provides Python access to openFDA endpoints for drugs, devices, foods, veterinary products, and substances, enabling regulatory analysis, safety monitoring, recalls tracking, and pharmacovigilance research.