FDA is on the war path
The recent spate of medical device recalls due to cybersecurity vulnerabilities prompted more stringent FDA recommendations. The distinction between connected medical devices ('tier 1') and detached devices ('tier 2') brought a plethora of new cybersecurity requirements for connected devices. These demands far exceed the level of cybersecurity usually displayed by medical devices. Among the new requirements are: strong cryptographic means, device specific encryption and verified execution.
Wether you want to seek re-approval of newer versions your existing product range, or enter the US market with a new product, you can save time and effort by relying on PROREGIA. With our cybersecurity concept and secure end-2-end framework, you no longer need to fear the FDA approval process. Strong cryptography, device-specific encryption, verified execution, and mobile device SDKs are just a few of the benefits of our end-2-end security product range.
Satisfy Uncle Sam by exceeding cybersecurity expectations.