The number of recalls also increased 21.5% this quarter, according to Stericycle’s Q3 2019 Recall Index.
Label and packaging artwork processes play an important role in meeting compliance for EU MDR.
This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
Software-powered PCBAs can help medical device engineers generate high-quality prototypes for complex electronics products in record speed.
Artificial intelligence and machine learning technologies have significant potential, but regulatory hurdles may stand in their way.
By simplifying labeling compliance, companies can focus on better serving current and new markets.
For reliable systems, we need a different mindset.
A recent project conducted by Northeastern graduate students looked at device recalls over the past five years and some of the common threads.
Going paperless is easier than you think.