“The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance.”
The AHRQ brief proposes a framework to assess the risk/safety, technical functionality and mental health features of apps. The framework can be used by advocacy organizations, payers, healthcare systems and others to inform selection of mental health mobile apps.
The center is proposing that Philips repair, replace or refund recalled devices manufactured after November 2015.
The catheter is part of the company’s transcatheter pulmonary valve system.
The pandemic forced patients and providers to rely on telemedicine, a change that has had a significant impact on the course of care. Experts discuss what can be accomplished with virtual care and what this means for the potential of medical devices.
The short answer is yes, but doing your homework in advance is now more important than ever.
Outdated policies and regulations threatens to bring progress to a standstill, restrict vital telehealth access to millions of Americans, and exacerbate health inequities.
On the journey to full-scale production for medical devices incorporating optics, a series of steps early in the process can make all the difference for successfully launching new products and introducing next-generation upgrades. This article discusses four considerations for a successful product launch.
FDA has issued a safety communication to alert patients and healthcare providers about the dangers of inappropriate use of NIPS tests.
The only constant today is change itself.