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septembre 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 Réglementations des dispositifs médicaux Affaires réglementaires 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.

Réglementations des dispositifs médicaux Dispositifs médicaux Interim Support Medical Device Compliance

Résultats

décembre 20, 2024

Full speed ahead with global market access in 2025!

As 2024 ends, Qserve reflects on a challenging yet transformative year in MedTech, highlighting global regulatory advancements and introducing innovative services—Qserve Learn and Qserve Insight—to empower companies in navigating compliance and planning for 2025.

novembre 12, 2024

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

octobre 29, 2024

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

octobre 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 Réglementations des dispositifs médicaux Dispositifs médicaux MedTech

octobre 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

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