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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

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

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

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).

Do you need help with regulatory strategies for AI medical device?

To put your AI medical device on the market, it is important to get your strategy right. Since most markets follow either the FDA or the EU approach, we will be looking into both, highlighting similarities and differences.

Key focus areas of Medical Device AI Compliance

In this blog, we will discuss the key focus areas of Medical Device AI compliance, focusing on the FDA and European regulatory frameworks.

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