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.

HSA on advertising (overview)

HSA Guidance on Advertisement Controls of Health Products: Overview

by | May 28, 2024 | HSA,Singapore | 0 Comments

The article provides a general overview of the existing legal framework for advertising healthcare products allowed for marketing and use in Singapore.
HSA on advertising (key aspects)

HSA Guidance on Advertisement Controls of Health Products: Key Aspects

by | May 28, 2024 | HSA,Singapore | 0 Comments

The new article describes in detail the key aspects related to the advertising activities in the context of medical devices intended to be marketed in Singapore.
FDA on tissue heating cooling devices (testing methodology)

FDA Guidance on Tissue Heating/Cooling Devices: Testing Methodology

by | May 22, 2024 | FDA,United States | 0 Comments

The new article provides additional clarifications regarding various testing methodologies to be used when assessing the thermal effect caused by medical devices when used for the intended purpose, as well as the risks associated with it.
FDA on tissue heating cooling devices (specific aspects)

FDA Guidance on Tissue Heating/Cooling Devices: Specific Aspects

by | May 22, 2024 | FDA,United States | 0 Comments

The new article outlines specific aspects associated with the evaluation of medical devices impacting the tissue temperature including, inter alia, the ones related to computational modeling as one of the assessment methods to be used.
HSA on product registration submission

HSA Guidance on Product Registration Submission

by | May 22, 2024 | HSA,Singapore | 0 Comments

The article provides a general overview of the regulatory framework for product registration submissions, including the relevant procedures for applying for marketing approval in Singapore.
Turkish guidance on calibration and testing

Turkish Revised Guidance on Testing, Control, and Calibration Activities: Overview

by | May 22, 2024 | TMMDA,Turkey | 0 Comments

The article highlights the critical points related to the legal framework for medical device testing, control, and calibration.
TGA on recalls (overview)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Overview

by | May 20, 2024 | Australia,TGA | 0 Comments

The article describes the recall procedures to ensure the continued safety of medical devices and other therapeutic products allowed for marketing and use in Australia.
TGA on recalls (step 1-3)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 1-3

by | May 20, 2024 | Australia,TGA | 0 Comments

The new article describes in detail the first three steps of a recall process, which include obtaining information and distribution status, conducting a risk analysis, and deciding on the type, class, and level of recall.
TGA on recalls (step 4-7)

TGA Guidance on Uniform Recall Procedure for Therapeutic Goods: Steps 4-7

by | May 20, 2024 | Australia,TGA | 0 Comments

The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA