New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
New changes mean new challenges, but global harmonization could make things easier for device manufacturers in the long run.
Some of the company’s V60 and V60 Plus ventilators were assembled with an expired adhesive, which could cause product failure.
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.
Thus far, the company has received 51 reports of serious injury and three reports of patient death over five years.
The feeding set tubing can become wrapped around a child’s neck, leading to strangulation or death.
Although the future is exciting, it also poses real challenges. More collaborative initiatives need to take place between drug manufacturers and developers of manufacturing equipment and consumables.
The Class I recall affects more than 95,000 devices in the United States.
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.
A capacitor manufacturing assembly error could cause the device to become inoperable.
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.