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
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
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
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 with Registration Tracker
Get your registration’s “big picture” in one simple graphic with RAMS automatic visual reports
Automated alerts simplify device registration tracking