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...

Medsafe on clinical trials (application process)
MedSafe Guidance on Clinical Trials: Application Process

by | Oct 1, 2024 | Medsafe,New Zealand | 0 Comments

The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
Medsafe on clinical trials (notification and GCP requirements)
MedSafe Guidance on Clinical Trials: Notification and GCP Requirements

by | Oct 1, 2024 | Medsafe,New Zealand | 0 Comments

The new article explains the requirements pertaining to notifications for clinical trials, as well as the Good Clinical Practice requirements.
MedSafe Guidance on Clinical Trials: Records and Reporting

by | Oct 1, 2024 | Medsafe,New Zealand | 0 Comments

The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
FDA on EST for De Novo (overview)
FDA Guidance on Electronic Submission Template for De Novo Requests: Overview

by | Oct 1, 2024 | FDA,United States | 0 Comments

The article highlights the key points related to the submissions associated with novel medical devices intended to be marketed and used in the US.
FDA-on-EST-for-De-Novo-specific aspects
FDA Guidance on Electronic Submission Template for De Novo Requests: Specific Aspects

by | Oct 1, 2024 | FDA,United States | 0 Comments

The new article provides additional details pertaining to the submission template to be used by the parties interested in applying for marketing permission for medical devices utilizing innovative technologies.
MHRA on quarterly summary reporting
MHRA on Quarterly Summary Reporting

by | Oct 1, 2024 | MHRA,UK,United Kingdom | 0 Comments

The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.
Swissmedic on combination studies (overview)
Swissmedic Information Sheet on Combination Studies: Overview

by | Oct 1, 2024 | Swissmedic,switzerland | 0 Comments

The article highlights the key points related to the regulatory requirements for combination studies intended to be carried out in Switzerland.
Swissmedic on combination studies (authorisation)
Swissmedic Information Sheet on Combination Studies: Authorisation

by | Oct 1, 2024 | Swissmedic,switzerland | 0 Comments

The new article provides further clarifications regarding the authorisation procedure to be followed by the parties interested in conducting combination studies in Switzerland.
Swissmedic on combination studies (modification)
Swissmedic Information Sheet on Combination Studies: Modifications

by | Oct 1, 2024 | Swissmedic,switzerland | 0 Comments

The new article clarifies the approach to be followed when introducing modifications to combination studies already approved by Swissmedic.