Skill UI

Manages corrective and preventive actions in medical device QMS, guiding root cause analysis with 5-Why and fishbone, action planning, effectiveness checks, and CAPA metrics.

Guides FDA medical device submissions, including 510(k), De Novo, and PMA pathways, QMSR compliance, HIPAA, and device cybersecurity. Includes scripts for submission tracking, QSR checks, and risk assessment.

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.

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.

Implement Okta as a centralized Identity Provider (IdP) for robust multi-cloud security across AWS, Azure, and GCP. This skill covers configuring Single Sign-On (SSO), deploying phishing-resistant Multi-Factor Authentication (MFA), automating user lifecycle management via SCIM, and enforcing adaptive access policies based on device posture and user risk, helping organizations achieve Zero Trust compliance.

Prepares US medical device companies for FDA inspections, internal QSR audits, and Form 483 responses. Covers complaint handling, process validation, device history records, CAPA effectiveness, and labeling compliance against 21 CFR and ISO 13485 standards. Generates compliance posture reports and identifies gaps before regulatory submissions.

This tool performs a rigorous, simulated Quality Management System (QMS) audit based on ISO 13485 standards for medical devices. It forces interrogation on critical areas, including Design History Files (DHF), CAPA effectiveness, process validation, risk management (ISO 14971), and post-market surveillance (MDR/FDA QSR). Use it before major audits, commercial launches, or regulatory submissions to identify compliance gaps.

A professional 3D mockup template for showcasing modern devices (iPhone, MacBook). It allows embedding real, dynamic HTML content directly into the screen canvas, simulating advanced product launches, app demos, or design presentations. Features include 3D rotation, glass lens refraction, and realistic reflections.

This skill queries and interprets the advanced Google Search Console AI Performance Report, covering both AI Overviews and AI Mode impressions and pages. It helps marketers baseline a brand's visibility in generative AI search results, assess performance by country, device, and date, and strategically decide on the in-Search-Console AI opt-out toggle. Essential for managing modern search attribution.