RegDesk: Revolutionizing Regulatory Management for Medical Devices

RegDesk: Revolutionizing Regulatory Management for Medical Devices

Summary:

The article discusses RegDesk’s regulatory management software for medical devices, highlighting its benefits and the evolving regulatory landscape in the EU, UK, Taiwan, and Korea.

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REGULATORY MANAGEMENT SOFTWARE REDUCES SUBMISSION TIME BY 80%

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

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

Save millions in lost revenue by not missing renewals

Increase global team efficiency by eliminating spreadsheets and silos

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

REGDESK REGULATORY ROUNDUP

The article provides an overview of the regulatory approach to be applied with respect to certain categories of innovative medical devices.

EUDAMED (European Database on Medical Devices) is an essential information system for the European Union’s regulatory framework for medical devices.

The Federal Institute for Drugs and Medical Devices (BfArM), the German regulating authority in the sphere of healthcare products, has published a notice dedicated to notifications of interruptions or terminations of the supply of medical devices the parties responsible should submit in order to communicate the crucial information to all the stakeholders involved.

The article provides a general overview of the regulatory framework for medical devices no longer supported by their manufacturers, emphasizing the key points to be taken into consideration in order to ensure the continued safety of patients.

In the highly regulated world of medical devices and in vitro diagnostics (IVDs), ensuring compliance with international standards is critical for market access and patient safety.

The new article provides an overview of certain aspects of the regulatory framework pertaining to contact lenses, namely, the matters associated with device identification.

The European Commission’s Health Technology Assessment Regulation (HTAR) marks a significant step toward harmonizing health technology evaluations across EU member states.

The article highlights the key points related to the UK regulatory framework for clinical investigations involving medical devices.

This article outlines the key steps and practices to ensure effective cybersecurity protocols.

In the rapidly evolving world of medical devices, keeping pace with regulatory changes is essential for success. As the global regulatory landscape undergoes significant transformation through 2024 and 2025, this comprehensive guide serves as a vital resource for medical device companies.

The article describes in detail the recent regulatory updates pertaining to medical device registration procedures in Taiwan.

The document provides an overview of the existing legal framework for innovative medical devices intended to be marketed and used in Korea.

In the ever-evolving world of medical devices, staying ahead of regulatory changes is crucial for success. Throughout 2024 and into 2025, the global regulatory landscape will continue to transform at an unprecedented pace.

In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in managing compliance and bringing their products to market efficiently.

The article provides a general overview of the regulatory approach to be applied with respect to corrective actions.

The new article further elaborates on the most crucial aspects related to corrective and preventative actions to be taken by the parties responsible for medical devices in order to ensure continued safety and proper performance.

The new article pays special attention to the role of the key parties involved.

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