Rapid FDA Approval
Your first US market medical device in record time - approval guaranteed.
The FDA toughened cybersecurity requirements for all connected medical devices. Make sure your device is fit for the US market.

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.

Uncle Sam demands more; be prepared!

Pre-approved components

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 with end-2-end seceurity by PROREGIA

Satisfy Uncle Sam by exceeding cybersecurity expectations.