REGULATORY MANAGEMENT SOFTWARE REDUCES SUBMISSION TIME BY 80%

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

Regulatory Management Software
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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

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

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.

AI Powered Regulatory Submissions: The Future of Compliance Management
AI-Powered Regulatory Submissions: The Future of Compliance Management

by | Jan 3, 2025 | Medical Devices,North America,RegDesk News/Info,RIMS,United States | 0 Comments

In today's rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in managing compliance and bringing their products to market efficiently. As a regulatory professional, you're likely all too familiar with the time-consuming and intricate process of preparing regulatory submissions. The use of AI streamlines this process to reduce errors, improve compliance and get your product to market faster.
MDCG on CAPA (overview)
MDCG Guidance on CAPA Plan Assessment: Overview

by | Dec 28, 2024 | MDCG | 0 Comments

The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.
MDCG on CAPA (key considerations)
MDCG Guidance on CAPA Plan Assessment: Key Considerations

by | Dec 28, 2024 | MDCG | 0 Comments

The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.
MDCG on CAPA (DA & JAT)
MDCG Guidance on CAPA Plan Assessment: DA & JAT

by | Dec 28, 2024 | MDCG | 0 Comments

The new article pays special attention to the role of the key parties involved.
FDA on air powered dental handpieces (overview)
FDA Guidance on Air Powered Dental Handpieces and Motors: Overview

by | Dec 28, 2024 | FDA,United States | 0 Comments

The article provides a brief overview of the applicable regulatory requirements set forth under the existing legal framework.
FDA on air powered dental handpieces (testing performance criteria)
FDA Guidance on Air Powered Dental Handpieces and Motors: Performance Criteria

by | Dec 28, 2024 | FDA,United States | 0 Comments

The new article describes in detail the applicable performance criteria to be taken into consideration by the parties responsible for medical devices covered by the scope of the guidance in order to ensure continued safety and proper performance of the latter.
DRAP on E-Reporting (overview)
DRAP Guidance on E-Reporting: Overview

by | Dec 28, 2024 | DRAP,Pakistan | 0 Comments

The article provides a general overview of the electronic reporting requirements in Pakistan.
DRAP on E-Reporting (content development)
DRAP Guidance on E-Reporting: Content Development

by | Dec 28, 2024 | DRAP,Pakistan | 0 Comments

The new article describes in detail the approach to be applied when it comes to content development.
Global Regulatory Trends & Updates for 2025: Navigating Compliance in Key Markets
Global Regulatory Trends & Updates for 2025: Navigating Compliance in Key Markets

by | Dec 28, 2024 | Medical Devices,North America,RegDesk News/Info,RIMS,United States | 0 Comments

As we look ahead to 2025, the global regulatory landscape for medical devices is set for significant evolution. With rapid technological advancements and a heightened focus on patient safety, regulatory bodies worldwide are adapting to ensure compliance while fostering innovation.
MDCG on MDR application to legacy devices (overview)
MDCG Revised Guidance on MDR Application for Legacy Devices

by | Dec 18, 2024 | EU,Europe,European Union,MDCG | 0 Comments

The article highlights the key points related to the regulatory status of legacy devices.
MDCG on MDR application to legacy devices (details)
MDCG Revised Guidance on MDR Application for Legacy Devices: Details

by | Dec 18, 2024 | EU,Europe,European Union,MDCG | 0 Comments

The new article provides additional clarifications regarding specific aspects of the regulatory approach to be followed.
FDA on endosseous dental implants (overview)
FDA Guidance on Endosseous Dental Implants: Overview

by | Dec 18, 2024 | FDA,United States | 0 Comments

The article provides a general overview of the applicable regulatory requirements and highlights the key points associated thereto.
FDA on endosseous dental implants (specific aspects)
FDA Guidance on Endosseous Dental Implants: Specific Aspects

by | Dec 18, 2024 | FDA,United States | 0 Comments

The new article describes in detail certain specific aspects related to the regulatory status of endosseous dental implants and performance criteria they should meet in order to be allowed for marketing and use in the US.
Cybersecurity in Medical Devices: Balancing Innovation and Compliance
Cybersecurity in Medical Devices: Balancing Innovation and Compliance

by | Dec 16, 2024 | Medical Devices,North America,RegDesk News/Info,RIMS,United States | 0 Comments

In today's rapidly evolving healthcare landscape, medical device manufacturers face the dual challenge of driving innovation while ensuring regulatory compliance. As connected devices become increasingly prevalent, cybersecurity has become a critical concern in regulatory submission.
FDA on radiation control regulations (general information)
FDA Guidance on Radiation Control Regulations: Specific Topics

by | 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 | 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 | 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 | 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 | 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 | 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.

RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.

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