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.

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.
FDA on radiation control regulations (general information)
FDA Guidance on Radiation Control Regulations: General Information

by | 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 | 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 | 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 on pharmacovigilance (overview)
DRAP Guidelines on National Pharmacovigilance System: Overview

by | 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 | 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 | 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 | 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 | 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 | 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 | 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.
DRAP on pharmacovigilance (structure)
DRAP Guidelines on National Pharmacovigilance System: Structure

by | Dec 11, 2024 | DRAP,Pakistan | 0 Comments

The new article describes in detail the current structure of the pharmacovigilance programme implemented in Pakistan.
DRAP Guidelines on National Pharmacovigilance System: PRAEC
DRAP Guidelines on National Pharmacovigilance System: PRAEC

by | Dec 11, 2024 | DRAP,Pakistan | 0 Comments

The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
DRAP on pharmacovigilance (stakeholders)
DRAP Guidelines on National Pharmacovigilance System: Stakeholders

by | Dec 11, 2024 | DRAP,Pakistan | 0 Comments

The new article outlines the main stakeholders of the pharmacovigilance system and highlights the key points associated thereto.
DRAP on pharmacovigilance (safety communication and risk minimization)
DRAP Guidelines on National Pharmacovigilance System: Safety Communication and Risk Minimization

by | Dec 11, 2024 | DRAP,Pakistan | 0 Comments

The new article provides additional clarifications regarding the approaches to be followed when communicating important safety-related information and also outlines special risk minimization measures to be taken by the parties involved.

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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