The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
The removal of communication barriers and ambiguity allows technology providers to focus on their own inherent system benefits.
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.
In the past, few people thought about medical devices falling victim to hackers. But as internet technology and changes in healthcare converge, medical devices are proving to be an easier target for hackers than we thought.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
There is no such thing as minimum or maximum compliance—there is just compliance.
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.