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.
How software is changing the legal landscape for medical device manufacturers.
The corrective action is intended to reduce the risk of patient harm as a result of cybersecurity vulnerabilities in the products.
High-resolution options can enhance patient care and safety, and surgical efficiency.
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.
When a software patch or device update cannot remedy a cyber threat, sometimes a recall is necessary.
The initiative also focuses on how devices will be regulated in the post-market world.
The demands of a connected device means product designers should change their approach to software development.
As software becomes more complex and connected, device manufacturers must address more risks.
Is your risk management process fully operational right now?