Compliance

How are we certified?

The entire platform is registered as a National Information System (NMI) under HSLF-FS 2022:42. The parts of the platform that meet the requirements for medical devices under the MDR, Triage24 and Smart Careplans, have been CE-marked under MDR class IIa since 2022. Since December 2024, Triage24’s CE marking (class IIa) has also covered the medical content and the search function.

Requirements for MDR certification

• Clinical evaluation

  Continuously assess the performance of our triage product and compare it with similar and alternative products, to ensure that we achieve at least the same accuracy as traditional triage carried out by healthcare staff.

• Post-market surveillance

  Continuously and over the long term ensure that the product meets the requirements of the regulatory framework.

• Risk management

  Assess the risks associated with each individual development initiative for our products, using mathematical and evidence-based methods.

We take it seriously

Security is Platform24’s highest priority. The foundation of our security posture is OWASP’s Application Security Verification Standard v4.0 (ASVS). This standard consists of 3 security levels, from level 1, which is intended for basic application of security, to level 3 (L3), which is far stricter and suited to security-critical applications. Due to the sensitive nature of the data handled and stored in the application, which is security-critical from a patient safety perspective, Platform24 has chosen to align its compliance with the level 3 requirements prescribed by ASVS.

Platform24’s architecture and the services built on it are fully scalable and efficient, and have been load-tested for handling sustained traffic of 240,000 concurrent users, with peaks of up to 300,000 concurrent users.

Platform24 is also certified under ISO 14001, ISO 27001, ISO 13485 and the Dutch standard NEN 7510.