A guide to what to expect during your certification audit and how to prepare.
The product can conduct electrocardiograms and measure the heart’s rhythms.
It is our responsibility to educate family and friends about the dangers associated with the practicing of backroom medicine.
The agency is aiming to provide more transparency and consistency in this area.
Following protocols and maintaining compliance have been common themes.
The decision was made after analyzing data from a long-term safety study.
It is one of the most basic of quality requirements.
As standards around interoperability emerge, now may be the time to look at the benefits of connected technologies.
The agency anticipates the program will result in a two-thirds reduction of the amount of device malfunction reports submitted by manufacturers.
Procedures for design validation must address risk analysis where appropriate.