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.

Navigating the Medical Device Approval Process
Navigating the Medical Device Approval Process: A Global Overview

by | Apr 23, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Entering the global medical device market is a complex journey that requires a deep understanding of diverse regulatory landscapes. From the United States to Japan, each country has its own set of rules, timelines, and expectations. 
Australia Complying with UDI timeframes
TGA Guidance on UDI Timeframes

by | Apr 22, 2025 | Australia, AusUDID, EU MDD, TGA | 0 Comments

The document provides an overview of the applicable regulatory requirements in the sphere of unique device identification.
Impact of FDA Staff Cuts on Patient Access to Medical Devices
Impact of FDA Staff Cuts on Patient Access to Medical Devices

by | Apr 17, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Jodi Granger is the Director of Regulatory Affairs at RegDesk. ​
Navigating ISO 13485 Compliance with RegDesk
Navigating ISO 13485 Compliance with RegDesk

by | Apr 16, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

In the highly regulated medical device industry, quality and compliance are non-negotiable. ISO 13485, the international standard for Quality Management Systems (QMS) in the medical device industry, plays a critical role in ensuring that manufacturers meet regulatory requirements for medical devices and in-vitro diagnostic products. 
Saudi Arabia MDS G26 Guidance on Comparison Diagnostic IVDs
SFDA Guidance on Companion Diagnostic IVDs

by | Apr 15, 2025 | KSA, Saudi Arabia, SFDA | 0 Comments

The Saudi Food and Drug Authority (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to companion diagnostic IVDs
Ensuring Compliance with Medical Device Packaging Validation Regulations
Ensuring Compliance with Medical Device Packaging Validation Regulations

by | Apr 10, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Packaging validation is a critical component of ensuring the safety, sterility, and integrity of medical devices.
Bosnia and Herzegovina: Recognition of EC Certificates
Bosnia and Herzegovina Guidance on Transitional Requirements

by | Apr 9, 2025 | EU, Europe, European Union, MDR | 0 Comments

The new article provides clarifications regarding the transitional arrangements associated with the changes in the legal framework.
Mastering Regulatory Change Management for Medical Device Companies
Mastering Regulatory Change Management for Medical Device Companies

by | Apr 4, 2025 | Medical Devices, North America, RegDesk News/Info, RIMS, United States | 0 Comments

Mastering regulatory change management is crucial for medical device companies to stay compliant and competitive in a rapidly evolving regulatory environment.
EU-Guidance on Classification Rules for in vitro diagnostic medical devices
MDCG Guidance on Classification Rules of IVDs

by | 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
The GSPR Checklist: Ensuring Compliance with EU MDR & IVDR

by | 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
MHRA Guidance on MD Regulations

by | 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
Understanding the Post-Market Surveillance Requirements Under the EU MDR

by | 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 | 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 | 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
How to Conduct a Successful Clinical Evaluation Under the EU MDR

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

by | 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 | 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
Understanding EUDAMED and Its Impact on Medical Device Compliance

by | 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 | 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.
MDA on obsolete and discontinued devices (overview)
MDA Guidance on Obsolete and Discontinued Devices: Overview

by | Feb 21, 2025 | Malaysia, MDA | 0 Comments

The article provides a general overview of the regulatory framework for medical devices no longer supported by their manufacturers, emphasizing the key points to be taken into consideration in order to ensure the continued safety of patients.