Clinical Trials
Clinical Trials

Transitioning EU Clinical Trials: Key Steps for Compliance by 2025

By Diede van Bladel

To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.

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Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR

By Prasad Ravichandran 

nsuring the safety and efficacy of medical devices/IVDs is paramount in the healthcare industry. This critical objective is achieved through comprehensive risk management practices, and two key frameworks play a crucial role: ISO 14971:2019 and the FDA Quality Management System Regulation (QMSR). This essay explores their individual contributions and how they work synergistically to enhance medical device safety.

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conformity
conformity

Conformity Assessment Guide: EU MDR and IVDR Compliance Strategies

By Joseph Richardson Larbi

Navigating the conformity assessment process – examination of a manufacturer’s technical documentation and quality management system – requires a thorough understanding of the different routes and options available for various risk classifications of medical devices and IVDs, while knowledge of the conformity assessment process helps manufacturers prepare effectively and manage expectations. This blog offers guidance for creating successful conformity assessments.

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Post-market surveillance
Post-market surveillance

Reliable Active Surveillance: RWE for MedTech

By Amelia Hufford, PhD, Phillip Stoltzfus

As regulatory bodies increasingly recognize the richness and value of RWE, particularly in informing the benefit-risk profile of devices from real-world environments, MedTech companies are turning to advanced analytical tools to navigate this new landscape efficiently.

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