Understanding Post-Market Surveillance:In the fast-paced world of medical technology, the journey of a medical device doesn’t end with regulatory approval. It continues into the...
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and...
The Food and Drug Administration (FDA) plays a pivotal role in safeguarding public health through the regulation of medical devices, ensuring that they are...
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant...
As we eagerly anticipate the 14th China International Medical Device Regulatory Forum (CIMDR) from March 30 to April 4, 2024, we find ourselves reflecting...
Execution of BD 2025 Strategy Driving Durable, Broad-Based Growth Q4 revenue of $5.1 billion increased 6.8% as reported and 5.9% on a currency-neutral...
SEOUL, South Korea, Oct. 24, 2023 /PRNewswire/ -- RF Medical, specializing in the treatment of tumors and veins with various radiofrequency ablation products, announced today...
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential...
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends the Medical Device Regulation...