In order to distribute medical devices in US, it is crucial for manufacturers to meet the established medical device cybersecurity requirements set out by the Food and Drugs Administration (FDA). This means that manufacturers must submit a premarket submission to the FDA to ensure that they are meeting the market access requirements.
These requirements include:
Applus+ Laboratories offers comprehensive cybersecurity testing services for evaluating medical devices in US / FDA Guidance on Cybersecurity in Medical Devices – Quality System Considerations and Content of Premarket Submissions.
For the cybersecurity testing, and generally for all documentation required by the standard, two levels are defined in: Basic Documentation Level and Enhanced Documentation Level.
Here are a few examples of how the different levels are applied:
Every medical device with a basic or higher documentation level must address a cybersecurity testing procedure. The evidence required to meet the cybersecurity testing standards is as follows (using the example of an implantable cardiac device with Bluetooth capabilities):
Contact Applus+ Laboratories to test and certify the cybersecurity of your medical devices!
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