REGULATORY MANAGEMENT SOFTWARE REDUCES SUBMISSION TIME BY 80%

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

Regulatory Management Software

TRUSTED BY LEADING COMPANIES

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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.

A Guide to Navigating Regulatory Compliance for Medical Devices

by | Jun 14, 2024 | Medical Device Regulation Resources | 0 Comments

Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat...

Medical Device Regulations in the United States

by | Jun 14, 2024 | United States,USA | 0 Comments

Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on...

Leveraging RIMS for Global Market Access
Leveraging RIMS Platforms for Global Market Access

by | May 29, 2024 | HSA | 0 Comments

Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue...

EU Q&A on interruption or discontinuation of supply (specific aspects)
EU Q&A on Information Obligations Associated with Interruption or Discontinuation of Supply: Specific Aspects

by | Nov 19, 2024 | European Commission,European Union | 0 Comments

The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
MHRA on future regulations (overview)
MHRA Guidance on Future Regulations: Overview

by | Nov 19, 2024 | Great Britain,MHRA,UK,United Kingdom | 0 Comments

The article describes in detail the approach the UK authority intends to apply when implementing amendments to the existing legal framework.
MHRA on future regulations (specific aspects)
MHRA Guidance on Future Regulations: Specific Aspects

by | Nov 19, 2024 | Great Britain,MHRA,UK,United Kingdom | 0 Comments

The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.
TMDA on Good Review Practices (overview)
TMDA Guidelines on Good Review Practices: Overview

by | Nov 19, 2024 | Tanzania,TMDA | 0 Comments

The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
TMDA on Good Review Practices (implementation)
TMDA Guidelines on Good Review Practices: Implementation

by | Nov 19, 2024 | Tanzania,TMDA | 0 Comments

The new article explains in detail the way the relevant principles and practices should be implemented in order to ensure the safety and proper performance of medical devices allowed for marketing and use in the country.
TMDA on Good Review Practices (MD regulation)
TMDA Guidelines on Good Review Practices: MD Regulation

by | Nov 19, 2024 | Tanzania,TMDA | 0 Comments

The new article provides additional details and extensive clarifications regarding the approach to the regulation of medical devices and diagnostic products.
EU Q&A on interruption or discontinuation of supply (manufacturers' obligations)
EU Q&A on Information Obligations Associated with Interruption or Discontinuation of Supply: Manufacturers’ Obligations

by | Nov 18, 2024 | European Commission,European Union | 0 Comments

The new article provides additional clarifications regarding the specific scope of information-related obligations medical device manufacturers should comply with.
EU Q&A on Information Obligations Associated with Interruption or Discontinuation of Supply

by | Nov 18, 2024 | European Commission,European Union | 0 Comments

The article highlights the key points related to the manufacturers’ obligations in case of product supply being interrupted or discontinued.
SFDA on innovative devices
SFDA Guidance on Innovative Medical Devices: Overview

by | Nov 18, 2024 | Saudi Arabia,SFDA | 0 Comments

The article outlines the basics of the regulatory framework for innovative medical devices.