Bollong.AI automates the documentation, data analysis, and decision support that technical founders usually buy from consultants. Submission-ready outputs you can hand to a regulatory agency, your board, or your contract manufacturer. Recommendations backed by real public data, not vibes. Eight months of consulting compressed into a workspace you can use yourself.
Submission-ready outputs you can hand to a regulatory reviewer, your board, or your CMO. Clearance-pathway drafts, design history file indexes, pitch decks, opportunity briefs— all generated from your structured project state, not from a fill-in-the-blank template.
Every recommendation traces back to real public data — regulatory filings, scientific literature, patent records, adverse-event databases. Predicate analyses cite the actual clearance. Safety signals link to the original report. No hand-waving— defensible work product you can show a regulator or an investor.
The technical heavy lifting consultants normally own — regulatory pathway analysis, design history files, risk management files, process FMEAs — automated into a workspace founders use themselves. You arrive at expert engagements with the foundation built, so consultants close the gap instead of starting from zero.
Try the platform before you commit. Type your idea, get back actionable intelligence drawn from real public data. No account required — the bollong.ai surface stores nothing, so searches happen in your session and disappear when you close the tab. Today’s free tools focus on medical-device founders; more verticals come online as we add subject-matter partners.
One device query searches the FDA 510(k) database, PubMed, ClinicalTrials.gov, and the USPTO. Surfaces regulatory pathway, predicate devices, safety signals, and competitive landscape in one view. Generates a downloadable Founder’s Opportunity Brief PDF you can share with consultants and investors.
Open MedValidator →Free · LiveUpload a Quality Manual or any SOP and get a structured, clause-by-clause gap analysis against ISO 9001, AS9100, ISO 13485, or IATF 16949. Identifies the standard automatically, scopes the analysis to the document uploaded, and appends known forthcoming changes (FDA QMSR Feb 2026, ISO 9001 next revision, AS9100 Rev E, IATF 16949 Rev 2). No signup. No storage.
Open QMS Gap Analysis →Free · LiveStrategic build-vs-buy analysis for medical-device components. Generates eleven panels in one AI request: 510(k) NRE, USPTO IP scan, FDA regulatory profile, PFMEA, manufacturing flow, Master Validation Plan, cost model, ROI, and the final make-vs-buy recommendation with capital ask.
Open MakeVsBuy →Build with usAre you the subject-matter authority for a regulated or specialized market? We partner with domain experts to launch new vertical apps on the Bollong.AI platform — you bring the expertise, we bring the engineering, infrastructure, and go-to-market. Revenue-shared from day one.
Pitch a vertical →You’re an invited tester — thanks for kicking the tires before the public launch. The links below drop you straight into seeded demo data for each workspace, no setup required. Sign in with the tester account we sent you.
The medical-device commercialization workspace. MNCMO portfolio with 100 projects across multiple customers — AI-drafted design outputs, verifications, dFMEAs, process flow, and Early Warning Signals on a curated subset. Sign in to explore.
Open MJAI demo →DemoThe universal founder workspace. Eight cards covering mission, formation, milestones, results, team, funding, documents, marketing — with sample content to show the shape and flow.
Open EJ demo →DemoA purpose-built workspace for university medical-device education. Students learn the full process and requirements of designing, validating, and submitting a real medical device — andthe business scaffolding required to commercialize it. AI personas combine senior-engineering depth with a tutor’s voice: every recommendation comes with the WHY, every input is a teaching moment. Faculty oversight across BioMedical, BioChemical, Mechanical, and Materials programs, with an Office-of-the-Provost cross-program view.
Open the demo →A universal founder workspace plus vertical-specific apps that go deep on your domain. Pick the one that fits where you are. Two are live today; more verticals follow as subject-matter partners come on board.
The universal founder workspace, vertical-agnostic by design. Eight cards covering mission, business formation, roadmap, team & stakeholders, documents & legal, funding & finance, and marketing plans. Pragmatic, structured progress any entrepreneur can show to investors — whether you sell software, services, or atoms.
Start 14-day trial →The specialized workspace for medical-device commercialization — the first vertical-specific app on the Bollong.AI platform. Eight stages from concept through 510(k) clearance: design controls, predicate research, Pre-Sub planning, QMS setup, funding strategy, pitch deck, consultant match, post-market. Includes a Manufacturing track for industrial automation projects.
Start 14-day trial →