The device is indicated for patients who have advanced heart failure and are not eligible for a transplant.
As medical device costs continue to be a growing area of hospital expenditures, many hospitals control the savings through device reprocessing programs. The shift toward planned obsolescence is especially troubling given the financial challenges many hospitals face.
Does your company understand the magnitude of the compliance effort?
A great idea is not the same as great execution.
The race to apply AI to medical treatment is rapidly accelerating in China and Japan.
The data that medical devices use is one of the most sensitive types of information.
Here’s what these three CEOs think about why the transition to digital is more important than ever.
An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.
The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.
A look at the pros and cons of connected medical devices.