Meriadoc

An agentic platform built exclusively for MDR.

The MDR pathway is expensive

Notified Body

You sign up with one, and it audits you.

External consultancy

Helps you understand what the Notified Body is asking for.

Internal team

Collects evidence, writes documentation and fixes it.

Generic AI tools like ChatGPT, Claude or Gemini help, until they hallucinate, make up regulatory articles or ignore parts of your documentation. You still end up reviewing everything by hand.

What Meriadoc does

Regulatory position

Assesses identification, intended purpose, device description, qualification and classification.

Gap finding

Cross-checks your documentation against the latest regulatory corpus.

Fixes

Proposes changes to close each gap.

Change monitoring

Flags potential problems when you edit your documentation by hand.

Start from scratch or connect your existing technical documentation.

Works with

Hardware and software medical devices

Physical devices, software as a medical device, or a combination of both.

Legacy or new devices

Already on the market, or seeking CE marking for the first time.

Join the waitlist

A few spots are already taken by the companies that helped us build Meriadoc. Leave your email to be an early adopter.