Creating a more efficient, accessible, and patient-centered health system
CitiusTech Senior VP and Market Head, Healthcare Providers, John Squeo, shares five game-changing shifts that will redefine the future of US healthcare and unlock a more streamlined, accessible and patient-centric system.
Risk Management in Medical Devices: Harmonizing ISO 14971-2019 & FDA QMSR
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.
Transitioning EU Clinical Trials: Key Steps for Compliance by 2025
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.
Addressing Challenges in Primary Packaging Testing for Medical Devices
This article discusses the challenges associated with the mechanical and container closure integrity (CCI) testing of medical device packaging, focusing on pouches and trays. In the medical device production environment, the packaging’s role is as crucial as the device itself, necessitating rigorous testing throughout the commercialization and production stages. A significant bottleneck identified in the testing process is specimen preparation, particularly when evaluating seal strength according to ASTM F88 or EN 868-5 standards, which often requires testing all four edges of the packaging. The article highlights the variability in specimen preparation methods, ranging from manual cutting techniques to more consistent pneumatic die punches, emphasizing the importance of minimizing operator influence to ensure accurate and repeatable test results.
5 Tips for Choosing a Reliable Testing Partner for Regulatory Success
Follow these tips when searching for the right third-party testing partner to avoid delays and ensure your product’s smooth journey to market.
2024 Medtech FDA Approval Volume Trends Down
Image Credit: ilkercelik via iStock / Getty Images Chec […]
Advances in 3D Printing Usher in the Next Wave of Orthopedic Casts
ActivArmor’s founder and CEO explains why 3D printing is changing the concept of orthopedics.
Medical Plastics 101: The Crystal-clear Benefits of Polycarbonate
The material’s strength, clarity, and toughness make it an obvious choice for a range of medical device applications.
The Role of Sensors in the Big Picture of Sustainability
Rethinking sensors can help reduce environmental impact.
Sensor Packaging: Critical MEMS Considerations
MEMS sensors offer precision and miniaturization.
