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September 09, 2024

Due Diligence in MedTech: The Importance of Regulatory Compliance

In this blog, we emphasize the importance of regulatory due diligence in the MedTech industry, highlighting how it safeguards against legal risks, ensures compliance with complex regulations across different markets, and is essential for the successful execution of transactions, whether launching a new medical device or acquiring a company.

Due Diligence Medical Device Regulations Regulatory Affairs Regulatory Compliance

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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October 16, 2024

Increased Scrutiny on Class A IVDs in Germany: What It Means for Manufacturers

Blog Class A Clinical Evaluation Germany In-Vitro Diagnostics IVD Compliance IVDR Post Market Surveillance Regulatory Affairs

October 16, 2024

Ten years of clarifying rules and increasing transparency

The past decade has brought significant changes to China’s medical device regulations, making the process clearer and more efficient for manufacturers. Discover how the new legal framework, enhanced transparency, and modern submission systems are shaping the market access landscape. Learn what steps you need to take to succeed in China, from compliance with EMC testing to navigating post-market surveillance.

China China Agent Market Access China Medical Device Regulations Regulatory News China medical device regulations EMC testing NMPA Post-market surveillance

October 08, 2024

China NMPA Proposes Legalization Reforms for Medical Device Administration

China China Agent Global Registration Market Access China NMPA Regulatory Affairs Regulatory News Services

October 03, 2024

Thank you for joining us at RAPS Convergence in Long Beach, California

Thank you for joining us at RAPS Convergence in Long Beach, California! Read in this blog about all Qserve's sessions and main key takeaways from the event.

CRO In-Vitro Diagnostics Medical Devices MedTech Qserve Group RAPS

September 27, 2024

Qserve's Mindy McCann Announced as 2024 RAPS Fellow

We are proud to share that Qserve's Principal Consultant, Mindy McCann, has been honored as a Fellow of the Regulatory Affairs Professional Society (RAPS).

Qserve Group Qserve Team RAPS

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