Regulatory updates keep 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
Quick guides to more than 20 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
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
Searchable database harnesses the expertise from a team of global RA experts
Gain insights
Get your registration’s “big picture” in one simple graphic with RAMS automatic visual reports
Automated alerts simplify device registration tracking
Easily prepare your FDA 510(k) submission, MDR TD File
Automated formatting guides you through document preparation
510(k) Builder integrates with FDA databases to find your product code, predicate device, and recognized standards
Create 510(k) submission that you can submit to US FDA
MDR Technical Documentation file incorporates references to external QMS for simpler updating
Create hyperlinks within the document to make it easier to navigate