The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
The omicron variant of the coronavirus has made clear that the impact of the pandemic is far from over, particularly for health systems and hospitals. The ongoing need to limit close contact between providers and patients means technology will continue to play a key role, but with that increased reliance on technology comes the heightened exposure to cyber risks, as well.
The threat of an attack is imminent. It is critical for medical devices and systems, as well as healthcare facilities to have the right safeguards in place.
The agency is encouraging medical device manufacturers to evaluate their risk and take action to remediate any vulnerability.
EU regulations require manufacturers of medical devices and systems prove the single-fault safety of their products. However, it is not clearly defined in detail how to comply with these requirements. This article explains which technical and legal requirements apply and which aspects should be considered during development.
This pioneering area of technology comes with new risks and questions of liability.
Medical device manufacturers can accelerate their digital transformation priorities through lean practices to better manage supply chain risk, complexity and disruptions.
Reported issues related to the device include two injuries and one death.
The company was accused of hiding serious health risks related to implantation of its transvaginal surgical mesh products.
Labeling is as critical as quality for medical device products. If a manufacturer can’t shift labeling to meet production in an agile manner, their products may not reach their destination.