Yes, there is a link between Form 483 observations and failing to conduct management reviews.
In the United States, nearly 4500 devices will be relabeled and 500 devices removed due to the risk of thrombus formation in the device.
10 factors design engineers must consider when creating stick-to-skin medical devices.
Cost savings and the ability to meet high-volume demands are enticing benefits.
The agency has alerted healthcare providers of unanticipated deaths related to the systems intended to treat obesity.
According to the Advocate General’s interpretation of the Directive and related soft law (i.e., MEDEV guidelines), software allowing the prescriber to detect contraindications, drug interactions and excessive doses shall qualify as a medical device.
Device establishments must maintain records of acceptable suppliers.
A guide to the steps companies can take to evaluate their device developer’s HFE process.
The Avalus pericardial surgical valve is intended for patients with aortic valve disease.
There is still much to learn about the benefits and potential of robotic surgery.