Medical Device Regulatory Classifier
Medical device classification for your product in one market: a cited memo on whether it is a regulated device, its likely class, the rules, standards and route to market.
Built for regulatory, product and founding teams scoping medical device classification before launch.
Why this work is hard
Regulatory, product and founding teams scoping a health product before launch spend hours on this by hand: finding the right sources, reading them, checking them against each other and writing up what matters. The work is repetitive, it is easy to miss something, and nobody can show where a claim came from.
Medical Device Regulatory Classifier does that work as a GREP AI agent. It runs when you ask, and you can put it on a daily, weekly or monthly schedule. Every run delivers a sourced report, with every claim linked to its source.
What you get
What Medical Device Regulatory Classifier delivers
FAQ
What does Medical Device Regulatory Classifier need to run?
Medical Device Regulatory Classifier needs product description and intended use and target market or jurisdiction; claims, features or technology to weigh (optional) is optional.
How often does Medical Device Regulatory Classifier run?
It runs when you ask, and you can put it on a daily, weekly or monthly schedule.
What does Medical Device Regulatory Classifier deliver?
Every run delivers a sourced report, with every claim linked to its source.
Can I change what Medical Device Regulatory Classifier does?
Yes. Every GREP AI agent can be cloned into your workspace, where you can edit its instructions, add your own sources and files, and change its schedule.
Which frameworks does it cover?
The one for your target market, such as EU MDR or IVDR, US FDA 21 CFR, UK MDR 2002, Health Canada, TGA or PMDA. It quotes the exact rule or code that applies.
Is this regulatory advice?
No. It is preliminary analysis, and a notified body or regulator decides. It flags ambiguity and the claim changes that would alter the class.
Does it look at comparable devices?
Yes. It checks predicate or comparable device listings such as FDA 510(k) or De Novo records and EUDAMED.
More agents like this
- Runs on demand
Audience & Customer Profile
AI-powered persona development that builds a sourced profile of your target buyers: priority segments, roles, pains in their own words, buying triggers, hangouts and purchases.
Sourced reportView → - Runs on demand
Business Tool Evaluator
An evidence-backed vendor evaluation for one tool or vendor: regulatory status, validation evidence, performance, risks, integration fit and pricing, with a verdict.
Sourced reportView → - Runs over a list on a schedule, weekly
Competitor Product Tracker
An AI competitor analysis tool that tracks what changed inside rival products: features, UX flows, pricing and paywalls, with before-and-after and user reaction.
Formatted briefView → - Runs on demand
Cross-Jurisdiction Regulatory Comparison
A cross-jurisdiction regulatory comparison: a side-by-side table showing how each named jurisdiction or regulator treats your issue, with position, key requirements, effective dates and citations.
Sourced reportView → - Runs on demand
Demo Script Builder
A demo script for one buyer: discovery questions by role, a timed run-sheet mapped to their priorities, likely objections and technical answers.
Word documentView → - Runs over a list on a schedule, weekly
Drug Safety & Shortage Watch
Weekly drug shortage and safety checks on every drug on your list: safety communications, label changes, recalls and shortages, with resupply dates where published, listed alternatives and sources.
Sourced reportView →
Run Medical Device Regulatory Classifier in minutes.
Free to start. Run it once, put it on a schedule, or clone it and make it yours.