Features

Navigate RA/QA activities with powerful tools to simplify your work and provide market insights

FDA 510(k) submission

Easily prepare MDD, MDR, or FDA documents with Smart Builder

Helps seamlessly transition between MDD to MDR regulatory schemes


Clear structure to create to create technical documentation compliant with MDD and MDR


Information auto-populates to reduce errors, speed up work, improve accuracy


510(k) Builder fully integrated with FDA databases for product code, predicate device, and recognized standards


Auto-formatting creates a ready-to-send 510(k) submission

RAMS Regulatory updates keep you informed

Regulatory Watch keeps you informed

Regulatory experts provide insights from around the globe on a regular basis


Options to organize your alerts to find the information most important to your business


Notifications regarding changes that could affect your product registration


Flag important items for additional follow-up

Simplify market expansion

Simplify market expansion

Quick guides to more than 30 markets provide a high-level overview into regulatory approval and make planning easy


Tools help you estimate the time and cost of regulatory approval for each country


Dozens of medical device and IVD registration documents to help you through device submission


A library of links to regulations and guidance documents published by regulatory authorities

 Valuable tools

Valuable tools

Estimate the time needed to secure FDA 510(k) clearance based on the type of product


FDA product classification lookup helps you understand what requirements apply to your device

Find answers

Find answers

Searchable database harnesses the expertise from a team of global RA experts

RAMS Registration Tracker

Gain insights with Registration Tracker

Get your registration’s “big picture” in one simple graphic with RAMS automatic visual reports


Automated alerts simplify device registration tracking

Ready for the next step? Register today.

Ready for the next step? Register today.