This series makes the argument for probability assessments in HFE/UE for medical devices and how to incorporate it into the paradigm.
The certification comes at a time when many companies have been saying that the May 2020 deadline is too soon.
Will more medical devices be impacted?
A U.S. launch of the product is expected in just a few weeks.
There are several critical questions that your internal team should be ready to address when preparing product portfolios and seeking out a CRO.
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Here’s a hint: EU MDR and recalls were among the hot topics.
As medical devices using software and wireless communication become more ubiquitous, hackers are becoming more advanced in their methods.
The agency granted its first approval order under the humanitarian device exemption in spinal pediatrics in the last 15 years.
Artificial intelligence and machine learning technologies have significant potential, but regulatory hurdles may stand in their way.