How software is changing the legal landscape for medical device manufacturers.
It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.
A cybersecurity researcher identified eight vulnerabilities, ranging in severity from low to critical, in Smiths Medical’s Medfusion 4000 wireless infusion pumps.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
When it comes to compliance, the FDA does not grant special dispensation.
Tips to navigate what can be a grueling undertaking.
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.
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.