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.