Module20 April 20264 min read
Module spotlight: Cybersecurity Assessment
A connected device is an attack surface. Cybersecurity assessment helps you identify and manage the security risks regulators now expect you to address.
By MoniDoseQMS Team
As medical devices connect to networks, phones, and the cloud, cybersecurity becomes a patient-safety issue. Regulators now expect manufacturers to assess and manage security risk across the product lifecycle. The cybersecurity assessment module gives you a structured way to do it.
What you can do
- Assess cybersecurity risks for connected devices
- Document threats, controls, and residual risk
- Connect security findings to risk management and software anomalies
- Maintain evidence for premarket and post-market security expectations
Why it matters
EU MDR Annex I (17.2) and FDA premarket cybersecurity guidance both require security to be designed in and maintained. Keeping cybersecurity assessment alongside risk and software work means security is part of the quality system, not a separate afterthought.