The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party...

Bioretec Ltd Company announcement 16 February 2024 at 8:00 a.m. TAMPERE, Finland, Feb. 16, 2024 /PRNewswire/ -- This announcement is a summary of Bioretec Ltd's...

Site initiation completed for first study ever to evaluate radiofrequency (RF) ablation in a transvascular approach to reduce the pain associated with pancreatic cancer...

In this webinar, you will learn how to prepare a verification and validation test plan for your 510(k) or De Novo submission. Your cart is...

The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing...

This blog provides a deep dive into the newest version of the FDA eSTAR, version 5.0, released on December 6, 2023. Why did the FDA...

Using the new FDA eSTAR template also requires a new process for eSTAR project management to prepare your 510k and De Novo submissions. Outline of...

HALIFAX, NS, Dec. 5, 2023 /PRNewswire/ - ABK Biomedical, Inc., an innovative, medical device company dedicated to the research, development, and commercialization of advanced...