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.
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.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
A look at the pros and cons of connected medical devices.
Smart medical devices will be a focus at the event’s Connected Health Forum.
Industry revenue was only up 4%, according to Ernst & Young’s annual Pulse of the Industry report.