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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

Results

November 12, 2024

MDCG Update: MDCG 2023-3 Rev. 1 with Questions and Answers on vigilance terms and concepts has been published

MDCG MedTech Vigilance

October 29, 2024

PPT Download | Mastering PMCF Data Collection: Overcoming Challenges to Achieve Success

October 29, 2024

An Exciting Week for Medtech in Europe – Combining Today's Implementation With Tomorrow's Improvements

Read in this blog by Gert Bos about recent regulatory conferences in Europe, including the RAPS Euro Convergence and Irish MedTech conferences, where participants actively engaged in discussions about fast-tracking EU MDR and IVDR implementation through European Parliament initiatives.

Blog Medical Device Regulations Medical Devices MedTech

October 24, 2024

On-Demand Webinar | Mastering PMCF Data Collection: Overcoming Challenges to Achieve Success

Learn in this on-demand webinar how to optimize your PMCF process, enhance data quality, and ensure regulatory compliance.

On-Demand Webinar PMCF

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

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