Consultant John Giantsidis, president of Boston-based CyberActa Inc., shares insights on the steps manufacturers can take to enhance the cybersecurity of their medical devices on Med Device Online.
Ensuring medical devices are trustworthy is vitally important as we become more dependent on them for reliable, secure, and safe operation. The FDA in its draft guidance defines a “trustworthy device” as a medical device containing hardware, software, and/or programmable logic that: (1) is reasonably secure from cybersecurity intrusion and misuse; (2) provides a reasonable level of availability, reliability, and correct operation; (3) is reasonably suited to performing its intended functions; and (4) adheres to generally accepted security procedures.
The question is: How do you prove (or improve) the trustworthiness of your medical device?…The following list of suggested activities is not exhaustive but provides the type of information and objective evidence that would ensure that when the time comes for a submission for commercialization and/or inspection, medical device manufacturers will be ready to prove the trustworthiness of their device.
Read more on Med Device Online.
