RegDesk Regulatory Compliance
Software

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.

TRUSTED BY LEADING COMPANIES

BENEFITS OF THE REGDESK COMPLIANCE PLATFORM

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

Testimonials

“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

Ethicon

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

Pharmaceutical

Comprehensive Regulatory Intelligence for:

  • Pharmaceuticals
  • Biologics
  • APIs
  • Excipients

Сountries we serve

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

REGDESK REGULATORY ROUNDUP

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

Serbian guidance on MD registration

Serbian Guidance on Amendments to MD Registration: Overview

by | Feb 23, 2024 | Serbia | 0 Comments

The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
FDA draft on 3P review (scope and definitions)

FDA Draft Guidance on Third Party Review Program: Scope and Definitions

by | Feb 23, 2024 | FDA,United States | 0 Comments

The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
TGA on QMS audits

TGA Guidance on QMS Audits and Certification: Overview

by | Feb 23, 2024 | Australia,TGA | 0 Comments

The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
FDA draft on 3P review (eligibility factors)

FDA Draft Guidance on Third-Party Review: 3P510k Eligibility Factors

by | Feb 21, 2024 | FDA,United States | 0 Comments

The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
FDA on real-world evidence (considerations on collection and analysis)

FDA Draft Guidance on Real-World Evidence: Considerations for Collection and Analysis

by | Feb 21, 2024 | FDA,United States | 0 Comments

The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA on real-world evidence (documentation overview)

FDA Draft Guidance on Real-World Evidence: Documentation Overview

by | Feb 21, 2024 | FDA,United States | 0 Comments

The new article highlights the aspects of the documentation the authority expects to be submitted for review.
MDCG on exemptions from clinical investigations

MDCG Guidance on Exemptions From Clinical Investigations

by | Feb 21, 2024 | EU,Europe,MDCG | 0 Comments

The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
FDA draft on 3P review (overview)

FDA Draft Guidance on Third Party Review Program and EUA: Overview

by | Feb 21, 2024 | United States,USFDA | 0 Comments

The article provides a brief overview of the existing legal framework associated with the third-party review.
SFDA on sample collection

SFDA Guidance on Medical Devices Samples Collection: Overview

by | Feb 21, 2024 | SFDA,South Africa | 0 Comments

The article provides an overview of the regulatory framework for sample collection.