The world of technology has opened many doors for healthcare innovation. We’ve worked with companies on medical devices to help them develop devices that will pass FDA and EU regulations.
Many of the new medical device designs where use is administered by a patient, will often call for an app. Such apps will still need to maintain the same level of security and quality required for the medical device. We can assist in this process.
In some cases, custom firmware will be required to customize the device functionality. We typically will recommend to work with semiconductor solutions that offer a strong SDK and solutions for OTA updates if needed.
If the medical device is “conneted”, then it will likely need a cloud backend. We can help develop the cloud solution for your medical device.
The requirements for a quality process to pass FDA or EU approvals are involved. We understand the process and can work within a quality system to help you get your product to market.