Frequently asked questions

Why is registration tracking important?

Medical device manufacturers are responsible for maintaining and renewing their medical device registrations in all countries where they are approved for sale. For many manufacturers, this means tracking hundreds, if not thousands, of registrations. Failing to renew a registration before its expiration date has serious consequences, including restrictions on sales and more difficult regulatory requirements.

Managing large amounts of data about your medical device registrations can be difficult and time-consuming. We’ve also found that the ways in which companies handle this information varies considerably – from manually editing spreadsheets to writing down registration details on paper notes.

RAMS-TRACK aims to make this task easier and more manageable so regulatory affairs specialists can minimize the risk of expired medical device registrations.

Is RAMS-TRACK validated in accordance with FDA and IEC guidelines?

Yes, RAMS-TRACK has been validated to confirm that it meets its intended use. If you need additional information about our validation activities, or if you would like our assistance with your validation of RAMS-TRACK, contact us.

Different countries have different re-registration times, so how does RAMS-TRACK know when to alert me about a registration that is expiring soon?

RAMS-TRACK's expiration alert dates can be set for each country in which you have registrations. RAMS-TRACK enables you to adjust the default alert date for each country and create custom alert dates for individual registrations.

Can my teammates access RAMS-TRACK?

Yes, you can add as many teammates to your RAMS-TRACK account as you wish. You can also control their access to view and modify registrations and certificates. You can even create accounts for your distributors and allow them to only view registrations for the products they distribute.

Does RAMS-TRACK keep track of edits to registration and certificate details?

Yes, RAMS-TRACK maintains audit trails of all registration and certificate modifications made by any member of your team.

Can I export my data from RAMS-TRACK?

Yes, you can export all your registration and certificate data to an Excel spreadsheet or to a PDF report.

Our registration data is sensitive. Will RAMS-TRACK keep it secure?

Yes, RAMS-TRACK conforms to industry best practices for security. If you would like additional details about our security procedures and policies, please contact us.