Medical device manufacturers must ensure the IT security of their devices. Regulations such as the FDA cybersecurity guidance documents demand a systematic approach
Parametrization of software seems promising: Fullfilling individual customer requirements with just one application. Mind the legal implications. Read how!
The standard family IEC 60601 is actually only applicable to medical electrical devices. But IEC 60601-4-5 is an exception: This standard for IT security has all medical products in the scope that they are integrated into IT networks. This also affects software as a medical device.