Simplify regulatory documentation with Smart Builder

Create your documentation faster and minimize errors that delay regulatory approvals.

Learn about RAMS Smart Builders

Smart Builders walk you through the FDA 510(k), MDD Technical File or Design Dossier, MDD CER, MDR Technical Documentation File, and MDR CEP and CER. This saves you time creating your documentation and minimizes errors that delay regulatory approval.

Learn about RAMS Smart Builders

Smart Builders walk you through the FDA 510(k), MDD Technical File or Design Dossier, MDD CER, MDR Technical Documentation File, and MDR CEP and CER. This saves you time creating your documentation and minimizes errors that delay regulatory approval.

Get it right the first time with intuitive form completion tools

This headache-free system for building and maintaining your registration dossier helps you avoid errors and inconsistencies that risk delaying or jeopardizing your market access.


Advance through every section with guidance on what each field should contain. The progress bar provides an at-a-glance snapshot of how far along you are.


Key textual components like the product name and Indications for Use can be recorded as keywords and applied throughout the document to ensure that they remain absolutely consistent.

Share notes and insights with the comment system

RAMS Smart Builders make it easy to coordinate edits and share progress with teammates. Track your progress, catch typos, and note outstanding needs.


Commenting gives you the ability to customize your project workflows to the dynamics of your team. Get the necessary information in one place where all the right people can see it!


Smart Builder also allows you to tag individual coworkers in your comments and notify them via email of any changes or assignments.

Generate a document that you can send right away

RAMS Smart Builders arrange your forms into a professional document pursuant to applicable regulatory requirements - there’s no need to spend further time on formatting.


Export a PDF of your completed submission that is ready to send without any hassle!

RAMS 510(k) Builder

RAMS 510(k) Builder walks you through your 510(k) documentation

Fully integrated with FDA databases that allow you to find your product code, predicate device, and recognized standards.


Automated formatting provides you with a no-fuss, ready-to-send 510(k) submission.


Form completion is easy to navigate and includes helpful explanations to avoid mistakes.


Insert hyperlinks to make it easier to navigate large files.

A woman's hands typing on a computer keyboard

Comply with the EU MDD, MDR, and MEDDEV 2.7/1

Smart Builders provide a clear structure to create medical device technical documentation compliant with MDD and MDR, with the potential to seamlessly transition between the two regulatory schemes.


Create a living document for your technical documentation and insert references to your QMS system for appendices documents for seamless updates.


Copy and import features that will sync between projects to make it easier to convert from MDD to MDR.


Additional savings will be available for users who choose to bundle the MDD and MDR Smart Builders for their technical documentation.

Ready for the next step?

Ready for the next step?