REGULATORY MANAGEMENT SOFTWARE REDUCES SUBMISSION TIME BY 80%

The only medical device RIM with integrated regulatory intelligence and AI automation.

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What is RegDesk?

Meeting various global rules is getting more complex, and changes are happening faster. To keep up, it’s crucial to invest in an all-in-one regulatory management software. RegDesk can help.

BENEFITS OF REGDESK'S RIM 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

Save millions in lost revenue by not missing renewals

Increase global team efficiency by eliminating spreadsheets and silos

Avoid stress and nonconformities from a Health Agency audit

Why RegDesk RIMS

With RegDesk, Regulatory Management software, enter over 120 global markets before your competitors. We make following global and local laws easy for specialized pharma and medical device companies.

This is what makes us unique

Integrated Regulatory Intelligence

Create a quick and reliable regulatory strategy and manage potential risks proactively with integrated 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

Cut your preparation, publishing, and submission time for global applications to just hours with 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)

Reduce staff hours and errors by auto-generating GSPR, Declaration of Conformity (DoC), and Essential Requirements documents with 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

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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

RegDesk is the only Regulatory Management Software that has built-in Regulatory Intelligence for:

Medical Devices
In Vitro Diagnostics

Software as a Medical Device
Radiation Emitting

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.

EU-Guidance on Classification Rules for in vitro diagnostic medical devices

MDCG Guidance on Classification Rules of IVDs

by adminrd | Apr 1, 2025 | EU, Europe, European Union, MDCG, MDR | 0 Comments

The article describes in detail the approach to be followed in order to determine the regulatory status and applicable regulatory requirements.

The GSPR Checklist: Ensuring Compliance with EU MDR & IVDR

by adminrd | Mar 27, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

The General Safety and Performance Requirements (GSPR) are a crucial component of the European Union’s regulatory framework for medical devices and in-vitro diagnostic devices, specifically under the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746).

MHRA Guidance on MD Regulations

by adminrd | Mar 25, 2025 | European Union, Great Britain, MHRA, UK, United Kingdom | 0 Comments

The article provides a general overview of the UK regulatory framework for medical devices.

Understanding the Post-Market Surveillance Requirements Under the EU MDR

by adminrd | Mar 20, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Post-market surveillance (PMS) is a critical component of the European Union Medical Device Regulation (MDR).

Guideline for Classification of Medical Devices and IVD

SAHPRA Guidance on Medical Device Classification

by adminrd | Mar 19, 2025 | RegDesk News/Info, SAHPRA, South Africa | 0 Comments

The article outlines the key points associated with the classification rules for medical devices.

Canada: Pre-Market Guidance for Machine Learning-Enabled Medical Devices

Health Canada Pre-market Guidance for ML-enabled Medical Devices

by adminrd | Mar 14, 2025 | GMLP, Health Canada | 0 Comments

The article describes in detail the regulatory requirements for certain innovative medical devices.

How to Conduct a Successful Clinical Evaluation Under the EU MDR

by adminrd | Mar 12, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Clinical evaluation is the cornerstone of the European Union Medical Device Regulation (MDR).

The Impact of the European Union Medical Device Regulation (MDR) on Manufacturers: Navigating New Requirements

by adminrd | Mar 6, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

The introduction of the European Union Medical Device Regulation (MDR) represents one of the most significant changes in the history of medical device regulation in Europe.

UK-MHRA on Software and AI as a medical device

MHRA Guidance on Software and AI as a Medical Device

by adminrd | Mar 5, 2025 | AI, Medical Devices, MHRA, SaMD, UK | 0 Comments

The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.

Understanding EUDAMED and Its Impact on Medical Device Compliance

by adminrd | Feb 28, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.

BfArM on Notification of Interruption or Termination of Supply

BfArM Notice on Interruption or Termination of Supply

by adminrd | Feb 27, 2025 | BfArM, European Union, Germany, MDCG | 0 Comments

The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a notice dedicated to notifications of interruptions or terminations of the supply of medical devices the parties responsible should submit in order to communicate the crucial information to all the stakeholders involved.