Technology should streamline the healthcare process for both patients and clinicians.
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
How software is changing the legal landscape for medical device manufacturers.
Growth of the Asian cloud computing market is expected to accelerate as healthcare providers streamline their operations in today’s paperless world.
A cybersecurity researcher identified eight vulnerabilities, ranging in severity from low to critical, in Smiths Medical’s Medfusion 4000 wireless infusion pumps.
Held in November, the COMPAMED and MEDICA trade fair will showcase futuristic as well as tried-and-true medical technologies.
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.