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.

FDA on radiation control regulations (general information)

FDA Guidance on Radiation Control Regulations: Specific Topics

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article provides a detailed overview of certain specific regulatory aspects associated with x-ray devices intended to be marketed and used in the US.

FDA on radiation control regulations (labeling)

FDA Guidance on Radiation Control Regulations: Labeling

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article provides extensive clarifications on labeling requirements to be followed in order to ensure all the vitally important information is duly communicated to end-users.

FDA on radiation control regulations (manufacture date and measurements)

FDA Guidance on Radiation Control Regulations: Manufacture Date and Measurements

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article clarifies the requirements pertaining to the date of manufacture and also highlights the measurement-related matters.

MDCG on borderline medical devices (combinations)

MDCG Guidance on Ethylene Oxide (EtO)

by adminrd | Dec 12, 2024 | MDCG,MDR | 0 Comments

The document provides an overview of the EtO regulatory status and highlights the key points to be taken into consideration by the medical device manufacturers utilizing it in their processes.

FDA on radiation control regulations (models and assembly requirements)

FDA Guidance on Radiation Control Regulations: Models and Assembly Requirements

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article addresses FDA guidelines related to models and assembly procedures for diagnostic X-ray equipment, emphasizing unique model identification, assembly responsibilities, and compliance with regulatory standards.

FDA on radiation control regulations (AROs and records)

FDA Guidance on Radiation Control Regulations: Models and Assembly Requirements

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article provides guidance on accidental radiation occurrences (AROs), record-keeping responsibilities, and managing defects in diagnostic x-ray systems.

FDA Guidance on Radiation Control Regulations: General Information

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article further describes the regulatory approach to be applied with respect to X-ray products, explaining the key concepts and ideas.

FDA on radiation control regulations (overview)

FDA Guidance on Radiation Control Regulations: Overview

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The article highlights the key points related to the radiation control legal framework.

FDA on radiation control regulations (fluoroscopy requirements)

FDA Guidance on Radiation Control Regulations: Fluoroscopy Requirements

by adminrd | Dec 12, 2024 | FDA,United States | 0 Comments

The new article focuses on fluoroscopic X-ray systems and the regulatory requirements established, particularly changes effective on June 10, 2006, providing guidance on compliance, system modifications, and operational features.

DRAP Guidelines on National Pharmacovigilance System: Overview

by adminrd | Dec 12, 2024 | DRAP,Pakistan | 0 Comments

The article provides a general overview of the pharmacovigilance system, highlighting the key points and aspects.

EDA on preclinical testing and clinical investigations (overview)

EDA Guidance on Preclinical Testing and Clinical Investigations: Overview

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The article outlines the key points associated with the testing medical devices should undergo in order to be allowed for marketing and use in Egypt.

EDA on preclinical testing and clinical investigations (classification and testing requirements)

EDA Guidance on Preclinical Testing and Clinical Investigations: Classification and Testing Requirements

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The new article provides further clarifications on the applicable classification system, as well as testing requirements to be considered.

EDA on preclinical testing and clinical investigations (clinical investigation)

EDA Guidance on Preclinical Testing and Clinical Investigations: Clinical Investigation Explained

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The new article explains the approach to be applied with respect to clinical investigations.

EDA on preclinical testing and clinical investigations (study design and risk management)

EDA Guidance on Preclinical Testing and Clinical Investigations: Study Design and Risk Management

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.

EDA on preclinical testing and clinical investigations (combination products and ethical considerations)

EDA Guidance on Preclinical Testing and Clinical Investigations: Combination Products and Ethical Considerations

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The new article pays special attention to combination products as a separate category of medical devices, and also highlights the key points related to ethical considerations.

EDA on preclinical testing and clinical investigations (safety reporting)

EDA Guidance on Preclinical Testing and Clinical Investigations: Safety Reporting

by adminrd | Dec 12, 2024 | EDA,Egypt | 0 Comments

The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.