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...

FDA on PPI in TPLC-PPI role
FDA Draft Guidance on Patient Preference Information in the TPLC: PPI Role

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article emphasizes the important role of patient preference information.
FDA on PPI in TPLC (practical considerations)
FDA Draft Guidance on Patient Preference Information in the TPLC: Practical Considerations

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article pays additional attention to the specific practical considerations pertaining to the use of patient preference information.
FDA on PPI in TPLC (FDA feedback)
FDA Draft Guidance on Patient Preference Information in the TPLC: FDA Feedback

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article highlights the aspects related to obtaining feedback from the authority in order to ensure compliance with the relevant regulatory requirements.
FDA on PPI in TPLC (additional considerations)
FDA Draft Guidance on Patient Preference Information in the TPLC: Additional Considerations

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article is dedicated to additional considerations to be taken into account when using patient preference information associated with medical devices intended to be marketed and used in the US.
FDA on PPI in TPLC (implementation)
FDA Draft Guidance on Patient Preference Information in the TPLC: Implementation

by | Oct 15, 2024 | FDA,United States | 0 Comments

The new article highlights the key points related to the actual implementation of the information collected from patients in the form of feedback.
BASG on drug-device combinatinos
BASG Notice on Drug-Device Combination Products

by | Oct 15, 2024 | Austria,BASG | 0 Comments

The article provides a general overview of the regulatory framework for combination products applicable in the EU in general and in Austria specifically.
India on GCP (overview)
CDSCO Guidance on Good Clinical Practices: Overview

by | Oct 15, 2024 | CDSCO,India | 0 Comments

The article highlights the key points related to clinical trials and the way they should be conducted in order to ensure the accuracy and reliability of the results, as well as the safety of the patients involved.
India on GCP (prerequisites)
CDSCO Guidance on Good Clinical Practices: Prerequisites

by | Oct 15, 2024 | CDSCO,India | 0 Comments

The new article pays special attention to the prerequisites of a clinical trial, addressing the matters related to protocols and key elements thereof.
India on GCP (ethical considerations and safety)
CDSCO Guidance on Good Clinical Practices: Ethical and Safety Considerations

by | Oct 15, 2024 | CDSCO,India | 0 Comments

The new article outlines the key ethical and safety considerations pertaining to clinical studies.