Simply stated, an inspection needs to add some value; otherwise, what’s the point?
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
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.