MAUDEMetrics: Open-source no-code desktop app (macOS, Windows) and Docker service for automated extraction and standardization of FDA MAUDE medical device adverse event data via the openFDA API. Bypasses the 26,000-record limit and produces reproducible, analysis-ready datasets — no programming required.

Decision-centric AI governance framework for biopharma/biotech development. Ten-question independent study on FDA reconstructability, AI accountability, and schema-validated decision logs.

RAG-powered AI assistant for querying FDA guidance documents and regulatory intelligence — with source citations, hallucination controls, and a governance framework for regulated life sciences deployment.

A curated list of resources for medical device regulatory professionals — agencies, standards, databases, tools, and educational content.

Interactive demonstration of how SMEDTEC Studio connects a brand's tools, suppliers and evidence into one owned compliance layer that reasons, but leaves every decision to you.

A minimalist and professional landing page for regulatory affairs and formulation training services.

This is my profile

AI-powered Regulatory Intelligence for Medical Devices. RAG pipeline with semantic reranking across EU MDR, MPDG, MepV, UK MDR, and more.

Python toolkit for generating FDA/IEC-compliant SaMD validation packages — IQ/OQ/PQ protocols, ISO 14971 risk management, IEC 62304 lifecycle, SBOM, and cybersecurity checklists.

The professional digital portfolio for Anthony R. Ball. A central hub detailing academic architecture, intellectual property, publications, and expertise in microbiology, regulatory affairs, and translational science.

Open FDA Complete Response Letter knowledge graph fused with the enforcement record (recalls, Import Alert 66-40, debarment). Vendor watch-list screener + grounded companion. Public FDA data, MIT, zero-dependency. Educational, not regulatory advice.

Interactive demonstration of SMEDTEC Studio Service: a bespoke product, supplier & compliance system built for clients on their own infrastructure.

MNC-style pharmaceutical pipeline asset assessment Agent Skill

RAPath Global Hub - Medical Device Regulatory Reference in Plain English. Properly sourced.