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February 03, 2025

Introducing Qserve Learn: A dedicated online learning platform for the Medical Device and IVD sector!

Qserve Learn is a flexible and comprehensive online training platform designed to equip clinical, regulatory, and quality professionals in the Medical Device and IVD sector with expert-led courses, virtual training, and on-demand resources to support their professional growth.

E-Learning Qserve Learn Training Virtual Training

Navigating MDR Challenges: How Qserve's Interim Support Can Optimize Your Medical Device Compliance

Explore how the European Union’s Medical Device Regulation (MDR) revolutionizes safety standards for medical devices while challenging companies' resources, and discover how interim support can be a game-changer in navigating these stringent new requirements.

Medical Device Regulations Medical Devices Interim Support Medical Device Compliance

Results

TGA Consultation on IVD Classification Changes – What You Need to Know?

The TGA is consulting stakeholders on proposed changes to IVD medical device classification and definitions to better align Australian rules with the European IVDR (Regulation 2017/746) where appropriate.

IVDR Medical Device Regulations Medical Devices

February 06, 2025

On-Demand Webinar | Essential Tips & Tricks for Launching a Clinical Study under MDR

Medical Device Regulations Medical Devices

February 03, 2025

Introducing Qserve Learn: A dedicated online learning platform for the Medical Device and IVD sector!

Qserve Learn is a flexible and comprehensive online training platform designed to equip clinical, regulatory, and quality professionals in the Medical Device and IVD sector with expert-led courses, virtual training, and on-demand resources to support their professional growth.

E-Learning Qserve Learn Training Virtual Training

January 23, 2025

The UK introduced the new Post Market Surveillance requirements

Read Our Latest Blog About the New UK Post-Market Surveillance Requirements. The UK’s updated Post-Market Surveillance (PMS) regulations for medical devices take effect on June 16, 2025, bringing new obligations for manufacturers, UK Responsible Persons (UKRPs), and Authorized Representatives.

Blog Brexit Guidance documents In-Vitro Diagnostics Medical Device Registration Medical Device Regulations Regulatory News UK Responsible Person UKCA

December 20, 2024

Full speed ahead with global market access in 2025!

As 2024 ends, Qserve reflects on a challenging yet transformative year in MedTech, highlighting global regulatory advancements and introducing innovative services—Qserve Learn and Qserve Insight—to empower companies in navigating compliance and planning for 2025.

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