“We process several hundred international applications per year. We would always experience delays. With RegDesk our team is able to generate applications within a few hours rather than months.”

Regulatory Affairs Manager, Medius-sized
medical device company

Medical Device Applications and Dossier Submission

RegDesk is the only regulatory intelligence platform that incorporates an A.I.-powered application builder. With our software you can prepare technical files in hours rather than months and submit applications faster for faster approvals.

 

Provides Guidance

Challenge:

Registering medical devices in other countries is a complex procedure that varies widely from country to country. Even with all the necessary regulatory intelligence, it’s easy to get lost on the labyrinthine path to approval.

Solution:

RegDesk’s application builder consolidates the entire submissions process into simple, fillable forms. Follow the prompts and our software will create a customized path to approval based on data entered.

Saves Time and Reduces Risk

Challenge:

Compiling the technical, legal and administrative documentation required for registering medical devices is a tedious and time consuming process. Errors made during this stage can snowball into rejections down the road.

Solution:

Regdesk’s AI-powered software automatically prepares jurisdiction-specific submissions dossiers based on product and regional targeting information. Data from past submissions is archived and used to autofill new applications.

Saves Time and Reduces Risk

Challenge:

Compiling the technical, legal and administrative documentation required for registering medical devices is a tedious and time consuming process. Errors made during this stage can snowball into rejections down the road.

Solution:

Regdesk’s AI-powered software automatically prepares jurisdiction-specific submissions dossiers based on product and regional targeting information. Data from past submissions is archived and used to autofill new applications.

Facilitates Updates to Existing Registrations

Challenge:

Nations vary in their requirements for registering changes to existing products. Updating registrations to reflect changes to products already on the market requires weeks of research and sometimes full resubmissions.

Solution:

RegDesk’s application builder integrates the largest and most up-to-date database of regulatory requirements on the web. Our software leverages this data to guide you through the process of updating your existing registrations, saving time and reducing the risk of non-compliance.

Why Choose US

With RegDesk your regulatory affairs team can prepare technical files in hours rather than weeks. Our AI-powered software guides applicants through region-specific national medical device registration processes, saving time and reducing errors. Archived data from previous registrations is used to autofill new applications, saving time.

 

Speak to a Regdesk Expert today!