RegDesk Regulatory Compliance

Regulatory Compliance Simplified

Eliminate the risk of lost revenue from missed deadlines, and prepare approval-ready international submissions in days instead of months. RegDesk simplifies compliance for specialized medical device and diagnostic companies globally.

Dashboard to track international registrations | RegDesk

Dashboard to track global registrations

What is RegDesk?

Complying with differing global regulations creates exponential complexity – and the pace of change continues to accelerate. To keep pace, investing in a holistic regulatory platform has become critical. RegDesk can help.



Prepare international applications within 1 week instead of 4 months

Reduce response time to address international inquiries from 6-8 weeks to less than 20 hours

Avoid stress and nonconformities from a Health Agency audit

Why RegDesk RIMS

With RegDesk, expand to 120+ global markets ahead of your competitors. We make compliance with global and local laws and regulations easy for specialized pharma and medical device companies.

This is what makes us unique

Regulatory Intelligence

Develop fast and reliable regulatory strategy and manage potential vulnerabilities proactively through our comprehensive regulatory intelligence.

  • Access up-to-date regulatory requirements for 120 markets
  • Receive daily alerts on changing regulations
  • Obtain timelines and costs per country

AI Submission Generator

Reduce your time to prepare, publish, and submit global applications from months to only a week using RegDesk’s AI technology.

  • Access country-specific, submission ready templates
  • Prepare and publish global applications in formats acceptable by regional health agencies
  • Leverage AI to autopopulate applications for subsequent countries

Tracking & Reporting

Monitor the entire lifecycle of your product and never again miss a renewal or ship a wrong product to a country.

  • Track the status of registrations by product name and SKU
  • Receive renewal notifications
  • Generate reports on key performance indicators within seconds

Standards Management

Maintain compliance of standards and guidances worldwide and avoid non-conformities from audits.

  • Search for international and country-specific standards and guidance documents
  • Manage gap assessments on standards through integrated workflows
  • Receive notifications on changing standards and guidance documents that affect your products

Change Assessment

Manage global impact of changes to a product faster and with ease through the Only Change Assessment Tool available with built-in regulatory intelligence.

  • Understand the regulatory impact of changes to an existing product
  • Generate report to see which products, countries, and SKUs will be impacted
  • Manage change control workflows to collaborate with internal and external teams

AI Form Builder (GSPR, DoC, Requirements)

Decrease staff hours and errors by auto-generating GSPR, Declaration of Conformity (DoC), and Essential Requirements documents using RegDesk’s AI capability.

  • Utilize AI and machine learning to auto-populate GSPR, DoC, and Essential Requirements
  • Track which submission documents require change when a standard changes
  • Automate bulk updates of the GSPR, DoC, and Essential requirements


“Automating our regulatory intelligence through RegDesk has been a great decision for our company. Our regulatory affairs team is much more efficient and we are better able to measure and track our KPIs.”

Kevin P., Vice President of Regulatory Affairs and Quality Assurance

Large Medical Device Company

“Overall, the experience with RegDesk and the team at RegDesk has been superior. Any question that our team had, RegDesk responded quickly and with potential solutions. RegDesk allowed our department to track, develop global strategies, work collaboratively with business partners globally, and expand market access of products. Prior to RegDesk many aspects were handled via email and implementing RegDesk allowed us to streamline, track, and gain efficiency in a global market.”

Elizabeth H., Senior Director, Regulatory Affairs

Large Medical Device Company

“Our regulatory affairs team saved quite a bit of time by having one centralized source to go to for global regulations and requirements. There is a serious convenience and simplicity factor involved when using RegDesk.”

Adam S., Director of Regulatory Affairs

Medium-Size Medical Device Company

“I had an excellent experience using RegDesk. The best thing about it is that the experts are very timely in their response and you get multiple, different opinions on your case. You get to look at them, see where they vary and don’t vary, and make more informed decisions based on that.”

Jacob M., Vice President of Regulatory Affairs

Large Medical Device Company

“RegDesk Alerts saved our regulatory affairs teams unprecedented amounts of time. Eliminating spreadsheets and automating regulatory intelligence has been a great business decision for us.”

Liz H, Senior Director of Regulatory Affairs

Medium-Size Medical Device Company

“RegDesk saved us 11 months of time. We will definitely be using them again.”

Chloe M., Regulatory Affairs Manager


Industries We Serve

Medical Device Graphic | RegDesk

Medical Device

Holistic RIM Solution with built-in Regulatory Intelligence for:

  • Medical Devices
  • In Vitro Diagnostics
  • Software as a Medical Device
  • Radiation Emitting
Pharmaceuticals Graphic | RegDesk


Comprehensive Regulatory Intelligence for:

  • Pharmaceuticals
  • Biologics
  • APIs
  • Excipients

Сountries we serve

We can help you expand to 120+ markets in the world.


Never miss a thing in the world of medical device regulatory compliance. The latest regulatory news and updates are always on our feed.

FDA Guidance on Informed Consent: Additional Elements

by | Sep 22, 2023 | FDA,United States | 0 Comments

The new article describes in detail the approach to be applied with respect to general operating systems and drivers used in medical devices, as well as safety measures...

MHRA Guidance on IVD Regulations: In-house Products

by | Sep 22, 2023 | MHRA,UK | 0 Comments

The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices.  Table of Contents The Medicines and Healthcare...

FDA Guidance on Informed Consent: Additional Elements

by | Sep 22, 2023 | FDA,United States | 0 Comments

The new article covers aspects related to additional elements of informed consent to be included where necessary.   Table of Contents The Food and Drug...

FDA Revised Guidance on Off-The-Shelf Software Use: Maintenance and Obsolescence

by | Sep 22, 2023 | FDA,United States | 0 Comments

The new article addresses aspects related to third-party software products used in medical devices in the context of maintenance and obsolescence.   Table of...

HSA Guidance on IVD Registration Submissions: Introduction

by | Sep 22, 2023 | Asia,Singapore | 0 Comments

The present article provides an overview of the most important aspects related to submissions for in vitro diagnostic medical devices.Table of ContentsThe Health...

HSA Guidance on IVD Analyzers: SMDR Listing Options

MHRA Guidance on IVD Regulations: Overview

by | Sep 22, 2023 | MHRA,UK | 0 Comments

The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. ...

FDA Guidance on Informed Consent: Risks and Benefits

by | Sep 22, 2023 | FDA,United States | 0 Comments

The new article addresses the FDA aspects related to the way information about risks and benefits associated with a clinical investigation should be communicated by a...

TGA Guidance on Reclassification of Spinal Implantable Medical Devices: Introduction

by | Sep 22, 2023 | Australia,TGA | 0 Comments

The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices.   Table of ContentsThe...

FDA Revised Guidance on Off-The-Shelf Software: Risk Assessment and Software Testing

by | Sep 22, 2023 | FDA,Uncategorized,United States | 0 Comments

The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA.  Table of ContentsThe United States...