Methods for self-validation of hardware and software for safety-critical medical devices

A method for self-validating compatibility of a peripheral electronic medical device, and a mobile communication device, comprising:

• verifying the presence of system minimum requirements of the mobile communication device;
• verifying an electronic communication connection between the peripheral electronic medical device and the mobile communication device;
• executing a connectivity test to evaluate electronic communication connectivity between the peripheral electronic medical device and the mobile communication device and subsequently disconnecting the electronic communication connection therebetween, wherein executing the connectivity test includes:
• reconnecting the electronic communication connection and subsequently checking latency of the reconnection;
• transferring data from the peripheral electronic medical device to the mobile communication device and checking a transfer rate of the transferred data;
• and
• checking a data integrity parameter;
• and
• assessing the result of the connectivity test.

A method for self-validating a medical device with a communication device, comprising:

• verifying system minimum requirements of the communication device;
• producing a wireless connection between the medical device and the communication device;
• initiating a test sequence and subsequently disconnecting the wireless connection;
• executing a test, comprising:
• reconnecting the wireless connection between the medical device and communication device and subsequently checking latency of the reconnection;
• transferring data from the medical device to the communication device and checking a transfer rate of the transferred data;
• and
• checking a data integrity parameter;
• and
• assessing a result of the test.