Cyber Essentials
Certification

To obtain Cyber Essentials certification, organisations must meet the following requirements: have a properly configured firewall, use secure configurations for devices and software, restrict user access to systems and data, protect against malware, and keep software up to date with patches.

Cyber Essentials certification is valid for 12 months. After this period, organisations need to renew their certification to maintain their cybersecurity credentials and demonstrate ongoing commitment to protecting against cyber threats.

No, Cyber Essentials Plus is an advanced level of certification that builds upon the requirements of Cyber Essentials. To obtain Cyber Essentials Plus, organisations must first achieve Cyber Essentials certification and then undergo additional independent testing.

While Cyber Essentials certification is not mandatory for all organisations, it is highly recommended for digital health companies that handle sensitive patient data. It helps demonstrate a commitment to cybersecurity and can provide a competitive advantage in the industry.

To meet IEC 62304 compliance, organizations must follow clear steps to manage the lifecycle of medical device software. This includes creating and maintaining plans for developing, testing, and maintaining the software to ensure it works safely and effectively. The software must be classified based on the level of risk it could pose to users, with stricter rules for higher-risk software. Teams must also identify and reduce any risks or problems with the software as it is being developed and after it is in use. Regular checks, testing, and updates are essential, and all work must be carefully documented to show how the software meets safety and quality standards.