[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"blog-introducing-orsd-open-regulatory-signal-dataset":3},["null","category",4,"content",5,"date",6,"description",7,"faq",8,"ogTitle",30,"readTime",31,"slug",32,"tags",33,"title",30],"Open Data","\u003Ch2 class=\"text-3xl font-bold mb-6\">Regulatory Data Should Be Open\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Regulatory filings are public records. When a company receives FDA 510(k) clearance, when a notified body issues an IVDR certificate, when ANVISA registers a new medical device — these are all government publications, accessible to anyone. In principle, this means every MedTech company, investor, and researcher has equal access to the same regulatory intelligence.\n\u003C\u002Fp>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  In practice, the data is scattered across dozens of agency websites, each with its own format, update schedule, and access method. Some agencies provide APIs, others require screen scraping, and many publish data in PDFs that need manual extraction. The cost of collecting, normalising, and maintaining this data at scale is prohibitive for most organisations — which is why regulatory intelligence has traditionally been the domain of expensive subscription services.\n\u003C\u002Fp>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  We believe this should change. That is why we are launching the \u003Cstrong>Open Regulatory Signal Dataset (ORSD)\u003C\u002Fstrong> — a public, open-licensed, machine-readable dataset of regulatory signals from every major market worldwide.\n\u003C\u002Fp>\n\n\u003Cdiv class=\"card bg-slate-50 dark:bg-slate-800 p-6 border-l-4 border-primary-500 my-8\">\n  \u003Ch3 class=\"text-xl font-bold mb-3\">ORSD at a Glance\u003C\u002Fh3>\n  \u003Cul class=\"space-y-2 text-slate-600 dark:text-slate-300\">\n    \u003Cli>\u003Cstrong>22+ data sources\u003C\u002Fstrong> across \u003Cstrong>10 regulatory jurisdictions\u003C\u002Fstrong>\u003C\u002Fli>\n    \u003Cli>\u003Cstrong>Free to use\u003C\u002Fstrong> — no registration, no API key required for read access\u003C\u002Fli>\n    \u003Cli>\u003Cstrong>Open license\u003C\u002Fstrong> — ODbL v1.0 \u002F CC0 1.0\u003C\u002Fli>\n    \u003Cli>\u003Cstrong>REST API\u003C\u002Fstrong> — JSON responses, no SDK required\u003C\u002Fli>\n    \u003Cli>\u003Cstrong>Growing daily\u003C\u002Fstrong> — new data sources and historical backfill in progress\u003C\u002Fli>\n  \u003C\u002Ful>\n\u003C\u002Fdiv>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">What Is in ORSD?\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  ORSD aggregates regulatory signals from three categories of public data sources:\n\u003C\u002Fp>\n\n\u003Ch3 class=\"text-2xl font-bold mb-4\">Regulatory Clearances & Certifications\u003C\u002Fh3>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Every medical device clearance, approval, and certification from major global regulators, including FDA 510(k) and PMA databases, EUDAMED (MDR and IVDR certificates), Health Canada MDALL, ANVISA (Brazil), NMPA (China), PMDA (Japan), TGA (Australia), MFDS (South Korea), CDSCO (India), and WHO Prequalification. Each record includes device classification, product code, applicant information, and decision date.\n\u003C\u002Fp>\n\n\u003Ch3 class=\"text-2xl font-bold mb-4\">Patent Filings\u003C\u002Fh3>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Patent grants and published applications from the USPTO, EPO, WIPO PCT, JPO, KIPO, and CNIPA — linked to medical device companies and technologies. Patent data provides early visibility into research direction and competitive positioning years before regulatory filings appear.\n\u003C\u002Fp>\n\n\u003Ch3 class=\"text-2xl font-bold mb-4\">Clinical Trials\u003C\u002Fh3>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Trial registrations from ClinicalTrials.gov, EU CTIS, and international registries, with sponsor information, device\u002Fprocedure classifications, enrollment numbers, and study status. Clinical trial activity is a leading indicator of future regulatory submissions.\n\u003C\u002Fp>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">Why Open Data?\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Open-sourcing regulatory data creates value that proprietary databases cannot match:\n\u003C\u002Fp>\n\n\u003Cdiv class=\"grid md:grid-cols-2 gap-6 my-8\">\n  \u003Cdiv class=\"card bg-white dark:bg-slate-800 p-6\">\n    \u003Ch4 class=\"text-lg font-bold mb-2\">🔬 Reproducible Research\u003C\u002Fh4>\n    \u003Cp class=\"text-sm text-slate-600 dark:text-slate-300\">\n      Academics, analysts, and regulators can build on the same data without negotiating data licenses. Every study, dashboard, or insight built on ORSD is reproducible by anyone.\n    \u003C\u002Fp>\n  \u003C\u002Fdiv>\n  \u003Cdiv class=\"card bg-white dark:bg-slate-800 p-6\">\n    \u003Ch4 class=\"text-lg font-bold mb-2\">🚀 Lower Barriers to Entry\u003C\u002Fh4>\n    \u003Cp class=\"text-sm text-slate-600 dark:text-slate-300\">\n      Startups and smaller teams can access regulatory intelligence that was previously only available through six-figure enterprise subscriptions. Free data means more competition and better products.\n    \u003C\u002Fp>\n  \u003C\u002Fdiv>\n  \u003Cdiv class=\"card bg-white dark:bg-slate-800 p-6\">\n    \u003Ch4 class=\"text-lg font-bold mb-2\">🌍 Global Coverage\u003C\u002Fh4>\n    \u003Cp class=\"text-sm text-slate-600 dark:text-slate-300\">\n      By aggregating 22+ sources into a single API, ORSD makes multi-jurisdiction regulatory analysis practical. Compare clearance timelines across markets, track global competitive activity, and identify cross-border patterns.\n    \u003C\u002Fp>\n  \u003C\u002Fdiv>\n  \u003Cdiv class=\"card bg-white dark:bg-slate-800 p-6\">\n    \u003Ch4 class=\"text-lg font-bold mb-2\">♻️ Community Contributions\u003C\u002Fh4>\n    \u003Cp class=\"text-sm text-slate-600 dark:text-slate-300\">\n      An open dataset invites community contributions — new data sources, better normalisation, additional fields. Over time, ORSD becomes more comprehensive than any single organisation could build alone.\n    \u003C\u002Fp>\n  \u003C\u002Fdiv>\n\u003C\u002Fdiv>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">Getting Started\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  ORSD is live and accessible now. No API key is required for basic read access — just send a request:\n\u003C\u002Fp>\n\n\u003Cdiv class=\"card bg-slate-900 dark:bg-slate-800 rounded-lg overflow-hidden my-8\">\n  \u003Cdiv class=\"flex items-center gap-2 px-6 py-3 bg-slate-800 dark:bg-slate-700 border-b border-slate-700\">\n    \u003Cspan class=\"w-3 h-3 rounded-full bg-red-400\" \u002F>\n    \u003Cspan class=\"w-3 h-3 rounded-full bg-yellow-400\" \u002F>\n    \u003Cspan class=\"w-3 h-3 rounded-full bg-green-400\" \u002F>\n    \u003Cspan class=\"text-sm text-slate-400 ml-2 font-mono\">Quick start\u003C\u002Fspan>\n  \u003C\u002Fdiv>\n  \u003Cdiv class=\"px-6 py-4 overflow-x-auto\">\n    \u003Cpre class=\"text-sm font-mono text-slate-200 dark:text-slate-200 leading-relaxed whitespace-pre-wrap\"># Check dataset stats\ncurl https:\u002F\u002Forsd.contextual-intelligence.org\u002Fv1\u002Fstats\n\n# Python\nimport requests\nstats = requests.get('https:\u002F\u002Forsd.contextual-intelligence.org\u002Fv1\u002Fstats').json()\nprint(f\"{stats['stats']['coverage']['data_sources']} data sources across {len(stats['stats']['coverage']['countries'])} jurisdictions\")\n\n# JavaScript \u002F Node.js\nconst stats = await fetch('https:\u002F\u002Forsd.contextual-intelligence.org\u002Fv1\u002Fstats').then(r => r.json())\nconsole.log(`${stats.stats.coverage.data_sources} data sources`)\u003C\u002Fpre>\n  \u003C\u002Fdiv>\n\u003C\u002Fdiv>\n\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Full API documentation is available on \u003Ca href=\"https:\u002F\u002Fcontextual-intelligence.org\u002Forsd\" class=\"text-primary-600 dark:text-primary-400 underline\">our website\u003C\u002Fa>. The dataset is updated continuously as agencies publish new data.\n\u003C\u002Fp>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">ORSD and the Contextual Intelligence Platform\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  ORSD is the data layer. The \u003Cstrong>Contextual Intelligence Platform\u003C\u002Fstrong> is what you build on top of it. While ORSD provides raw regulatory signals, the platform adds:\n\u003C\u002Fp>\n\n\u003Cul class=\"space-y-3 text-slate-600 dark:text-slate-400 mb-8\">\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Semantic knowledge graphs\u003C\u002Fstrong> that correlate regulatory filings with patents, clinical trials, grants, and market data — revealing strategic context that raw signals cannot show\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Automated alerts\u003C\u002Fstrong> via email, Slack, and webhook — know when a competitor files, receives clearance, or enters a new market\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Custom dashboards and reports\u003C\u002Fstrong> tailored to your competitive set, product categories, and geographies of interest\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>API access with higher rate limits\u003C\u002Fstrong> and dedicated support for enterprise integrations\u003C\u002Fspan>\n  \u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  Think of ORSD as the foundation — free and open for everyone — and the CI Platform as the premium layer that turns data into decisions.\n\u003C\u002Fp>\n\n\u003Cdiv class=\"card bg-gradient-to-br from-primary-50 to-accent-50 dark:from-slate-800 dark:to-slate-800 p-8 rounded-xl my-8 text-center border border-primary-200 dark:border-primary-900\">\n  \u003Ch3 class=\"text-2xl font-bold mb-3\">Get Early Access\u003C\u002Fh3>\n  \u003Cp class=\"text-slate-600 dark:text-slate-400 mb-4 max-w-lg mx-auto\">\n    The dataset is growing daily. Subscribe for updates, new data source announcements, and early access to the full ORSD release — including a free API key.\n  \u003C\u002Fp>\n  \u003Ca href=\"\u002Forsd\" class=\"inline-block px-8 py-3 bg-primary-600 text-white rounded-lg font-semibold hover:bg-primary-700 transition-colors\">\n    Get Your Free API Key\n  \u003C\u002Fa>\n\u003C\u002Fdiv>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">What Is Coming Next\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  ORSD is version 0.1 — a foundation, not a finished product. Here is what we are working on next:\n\u003C\u002Fp>\n\n\u003Cul class=\"space-y-3 text-slate-600 dark:text-slate-400 mb-8\">\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Historical backfill\u003C\u002Fstrong> — FDA 510(k) data going back to 2010, EUDAMED certificates from initial MDR\u002FIVDR implementation, and multi-year patent and clinical trial archives\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Additional data sources\u003C\u002Fstrong> — Saudi Arabia (SFDA), Mexico (COFEPRIS), Singapore (HSA), and more\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>SDK and client libraries\u003C\u002Fstrong> — official Python, JavaScript, and Go clients\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Data downloads\u003C\u002Fstrong> — periodic full-dataset exports for offline analysis\u003C\u002Fspan>\n  \u003C\u002Fli>\n  \u003Cli class=\"flex gap-3\">\n    \u003Cspan class=\"text-primary-600 font-bold shrink-0\">→\u003C\u002Fspan>\n    \u003Cspan>\u003Cstrong>Community contribution guide\u003C\u002Fstrong> — documentation for adding new data sources and improving normalisation\u003C\u002Fspan>\n  \u003C\u002Fli>\n\u003C\u002Ful>\n\n\u003Ch2 class=\"text-3xl font-bold mb-6 mt-12\">Join Us\u003C\u002Fh2>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  ORSD is a bet that open data creates more value than proprietary silos. We are inviting the regulatory intelligence community — MedTech companies, investors, consultants, academics, and regulators — to use the dataset, contribute feedback, and help shape its direction.\n\u003C\u002Fp>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-6 leading-relaxed\">\n  The dataset is free. The API is live. Get started today.\n\u003C\u002Fp>\n\u003Cp class=\"text-slate-600 dark:text-slate-400 mb-8 leading-relaxed\">\n  \u003Ca href=\"https:\u002F\u002Forsd.contextual-intelligence.org\" class=\"text-primary-600 dark:text-primary-400 underline font-medium\">Explore the ORSD API →\u003C\u002Fa>\u003Cbr>\n  \u003Ca href=\"\u002Forsd\" class=\"text-primary-600 dark:text-primary-400 underline font-medium\">Get your free API key →\u003C\u002Fa>\u003Cbr>\n  \u003Ca href=\"https:\u002F\u002Fcontextual-intelligence.org\u002Forsd\" class=\"text-primary-600 dark:text-primary-400 underline font-medium\">Get your free API key →\u003C\u002Fa>\n\u003C\u002Fp>","2026-07-14","We are open-sourcing regulatory intelligence. The Open Regulatory Signal Dataset (ORSD) provides FDA clearances, EUDAMED certificates, ANVISA registrations, patent filings, and clinical trial data from 22+ sources — free to use under ODbL\u002FCC0.",{"@context":9,"@type":10,"mainEntity":11},"https:\u002F\u002Fschema.org","FAQPage",[12,18,22,26],{"@type":13,"name":14,"acceptedAnswer":15},"Question","What is ORSD?",{"@type":16,"text":17},"Answer","The Open Regulatory Signal Dataset (ORSD) is a public, open-licensed dataset of regulatory signals from 22+ data sources across 10 jurisdictions. It includes FDA clearances, EUDAMED certificates, ANVISA registrations, patent filings, and clinical trial data, all accessible via a free REST API.",{"@type":13,"name":19,"acceptedAnswer":20},"Is ORSD really free?",{"@type":16,"text":21},"Yes. ORSD is licensed under ODbL v1.0 and CC0 1.0. Basic read access to the API requires no registration or API key. We offer premium API keys with higher rate limits as part of the Contextual Intelligence Platform.",{"@type":13,"name":23,"acceptedAnswer":24},"How is ORSD different from the Contextual Intelligence Platform?",{"@type":16,"text":25},"ORSD is the raw open data layer — regulatory signals in structured JSON format. The CI Platform builds on ORSD with semantic knowledge graphs, cross-domain correlation (regulatory + patent + clinical trial + grant data), automated alerts, custom dashboards, and enterprise API access.",{"@type":13,"name":27,"acceptedAnswer":28},"What data sources are included?",{"@type":16,"text":29},"ORSD currently covers 22+ data sources including FDA (510(k), PMA, De Novo), EUDAMED (MDR\u002FIVDR), ANVISA (Brazil), NMPA (China), PMDA (Japan), Health Canada, TGA (Australia), MFDS (South Korea), CDSCO (India), WHO Prequalification, USPTO, EPO, WIPO PCT, ClinicalTrials.gov, and EU CTIS.","Introducing ORSD: A Free, Open Regulatory Signal Dataset",6,"introducing-orsd-open-regulatory-signal-dataset",[34,35,36],"open-data","regulatory-intelligence","api"]