Sorry, I am not available for hire right now. I have some experience with regulated software for medical devices, but any generic developer could learn the regulatory requirements with a little effort. Mostly related to ISO 62304 and in general ISO 13485. The tools to meet regulatory compliance are general tools developers employ in most projects already. The important part is that the development process is formally defined.
The device I worked on was classified as IIa. There was a focus on a thorough risk analysis and we ensured mechanism were in place to shut down the device in any case of emergency.
I don't want to say what kind of device it was, it had to do with higher frequency ultrasonic sensory.
The device I worked on was classified as IIa. There was a focus on a thorough risk analysis and we ensured mechanism were in place to shut down the device in any case of emergency.
I don't want to say what kind of device it was, it had to do with higher frequency ultrasonic sensory.