In recent years, cybersecurity in medical devices has become a critical issue. Regulatory bodies, such as the FDA and EU via the MDR, have responded by tightening their requirements.
A shared responsibility
Cybersecurity cannot be delegated to a single team or a single phase. It is a shared responsibility: between development and regulatory, between manufacturer and supplier, between market entry and post-market surveillance.
Security by design
Zentis embeds cybersecurity from the first architecture discussion. Threat modelling, secure boot, encrypted communication, and update mechanisms are architectural decisions, not afterthoughts. We align with MDCG 2019-16 for EU submissions and FDA cybersecurity guidance for US submissions.
The regulatory landscape
MDCG 2019-16 provides detailed guidance on cybersecurity for medical devices in Europe. Both EU and FDA require manufacturers to demonstrate a systematic approach to identifying, managing and communicating cybersecurity risks throughout the product lifecycle.
