Structured facts
The output separates supplied facts from unknowns and preserves market-specific status.
Free regulatory product master · No signup
Build one reusable medical device or IVD product profile
Stop retyping the same manufacturer, site, intended-use, model, approval, certificate, and evidence facts. Paste what you have and download a structured JSON and branded Excel master.
Fixed JSON contractEditable Excel workbookMissing facts stay emptyReuse across downstream tools
Paste the product information you already have
Pi separates organizations, sites, products, models, classifications, approvals, certificates, claims, and evidence into one fixed JSON contract. Formatting and language can be mixed.
Do not paste patient data, passwords, or unauthorized confidential information.0 / 50,000
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
Operational workbook
Dedicated Excel sheets make the profile usable outside the browser.
Connected workflows
Carry a compact product context into classification, dossier, testing, form, and launch tasks.
Regulatory product profile FAQ
What is a regulatory product master?
It is a structured source of product, company, site, model, market authorization, certificate, claim, and evidence facts that can be reused across regulatory tasks.
Does the tool save a permanent product database?
No. The free tool returns JSON and Excel for you to keep. It does not create a persistent account or system of record.
Will the agent guess missing classifications or registrations?
No. It distinguishes confirmed, claimed, hypothetical, and unknown status and records material missing facts and conflicts.
Can I use the result in other Pure Global tools?
Yes. The page offers connected paths into classification, registration planning, dossier analysis, standards/testing, and market-launch workpapers.