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二月 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

六月 10, 2024

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

结果

七月 24, 2025

Understanding the FDA 510(k) submission process

A 510(k) is a submission file used to obtain FDA clearance for medical devices. It's the most common pathway for bringing medical devices to the US market.

七月 17, 2025

How does collaboration with a consultancy partner in regulatory consultancy work?

Conducting thorough yet efficient due diligence presents unique challenges in medical technology investments that demand specialized approaches.

Blog Due Diligence

七月 10, 2025

When do you need regulatory due diligence for MedTech acquisitions?

Regulatory due diligence is nowadays crucial for mergers and acquisitions in MedTech. The acquiring company must have a clear understanding of the regulatory risk profile of the target company and place the existing risks in the context of the potential acquisition.

Blog Due Diligence

七月 09, 2025

Things you need to know about market access in Singapore

In Singapore, the Health Sciences Agency (HSA) regulates the import, manufacturing, export and supply of medical devices to safeguard public health safety.

Global Registration Legal representation Singapore

七月 03, 2025

The impact of regulatory changes on the value of MedTech businesses

The MedTech sector faces unprecedented regulatory overhaul, particularly with Europe's transition from the Medical Device Directive (MDD) and In Vitro Diagnostic Directive (IVDD) to the more stringent Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

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