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.
Health technology developers need to prioritize security from the moment a device or platform is first incepted.
Class I device manufacturers need to keep on top of new classification rules to avoid loss of market share under the close approaching EU MDR deadline.