RegDesk Regulatory Compliance
Software For Medical Devices

Regulatory Compliance Simplified

The only RIM platform, with built-in regulatory intelligence and AI-powered automation that allows management of change assessment and preparation of international submissions within hours compared to months.

Dashboard to track international registrations | RegDesk

Dashboard to track global registrations

What is RegDesk?

Complying with differing global regulations creates exponential complexity – and the pace of change continues to accelerate. To keep pace, investing in a holistic regulatory platform has become critical. RegDesk can help.

TRUSTED BY LEADING COMPANIES

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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, expand to 120+ global markets ahead of your competitors. We make compliance with global and local laws and regulations 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...

HRPA on Clinical Investigations
HPRA Guidance on Clinical Investigations: Overview

by | Jun 19, 2024 | HPRA,Ireland,MDCG | 0 Comments

The article highlights the key points related to the current regulatory framework for clinical investigations conducted in Ireland.
TGA on sponsorship changes
TGA Guidance on Notification in Sponsorship Changes

by | Jun 19, 2024 | Australia,TGA | 0 Comments

The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
MDA on change notification (overview)
MDA Draft Guidance on Change Notification: Overview

by | Jun 19, 2024 | Malaysia,MDA | 0 Comments

The new article highlights the key points related to the change notification procedure applicable to medical devices allowed for marketing and use in Malaysia.
NHRA on MDR transition
NHRA Guidance on MDR Transition

by | Jun 19, 2024 | Bahrain,Europe,NHRA | 0 Comments

The National Health Regulatory Authority (NHRA), a Bahrain’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the transition from Medical Directives to Regulations - the new regulatory framework recently adopted in the European Union. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in operations with medical devices in order to ensure compliance thereto. At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Furthermore, the authority reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
TGA MD EP Checklist
TGA Medical Device Essential Principles Checklist

by | Jun 13, 2024 | Australia,TGA | 0 Comments

The article provides an overview of a checklist outlining the main principles to be considered with respect to medical devices intended to be marketed and used in Australia.
MHRA Revised Guidance on Clinical Investigations (Considerations)
MHRA Revised Guidance on Clinical Investigations: Considerations

by | Jun 13, 2024 | Great Britain,MHRA,United Kingdom | 0 Comments

The new article elaborates further on special considerations associated with clinical investigations involving medical devices intended to be marketed and used in the UK, highlighting the most important aspects.
MHRA Revised Guidance on Clinical Investigations (Decisions and Circumstances)
MHRA Revised Guidance on Clinical Investigations: Decisions and Circumstances

by | Jun 13, 2024 | Great Britain,MHRA,United Kingdom | 0 Comments

The new article describes in detail the approach to be followed when deciding whether clinical investigations are necessary and also elaborates more on the circumstances associated thereto.