“Our regulatory affairs team saved quite a bit of time by having one centralized source to go to for global regulations and requirements.”

Director of Regulatory Affairs, Medium-Sized
Medical Company

Medical Device Regulatory Intelligence Platform

Every journey begins with a single step. The most important step to introducing your medical products to new markets is initial intelligence gathering. RegDesk saves time and reduces risk by providing the most comprehensive, up-to-date regulatory intelligence on the web. Global medical device registration requirements are condensed into easy-to-follow steps and translated to English when necessary.

 

Instant Access to Global Regulatory Requirements

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.

Up-To-Date Requirements

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.

Up-To-Date Requirements

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.

Regulatory Requirements that are Easy to Understand

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

The medical device industry is evolving quickly in response to recent innovations in communications and data processing technology. Relying on search engines or industry consultants to gather regulatory intelligence is as old-fashioned now as relying on print publications seemed ten years ago. Now is the time to adopt new solutions to age-old problems like expanding to foreign markets.

Speak to a Regdesk Expert today!