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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

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August 01, 2025

The impact of FDA Regulations on your medical device

Manufacturers face critical decisions about market entry strategies because of the changing European medical device regulations. In this blog, we explore the impact of FDA regulations on medical device development and market access strategies, providing insights for manufacturers of medical devices.

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.

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

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

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