Compliance

MDR Certified Triage and Remote Patient Monitoring

Platform24’s triage product is certified in accordance with MDR. With the certification, we have high demands on us to ensure quality, clinically support, assess risk and monitor the medical devices that are placed on the market.

With an MDR-certified product, you can feel confident that we, as a company, are able to conduct long-term, responsible product development for medical technology software.

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 performed by healthcare professionals.

Post-market surveillance

Continuously and long-term ensure that the product meets the requirements of the regulations.

Risk management

Mathematically and evidence-based assess the risks associated with each individual development initiative regarding our products.

We take it seriously.

Security is a top priority for Platform24. The basis of our security posture is OWASP’s Application Security Verification Standard v4.0 (ASVS). This standard mandates 3 levels of security posture, from level 1 intended for basic application security to level 3 (L3) which is much more strict and is suitable for critical applications. Due to the sensitive and, from a patient safety perspective, critical nature of the data handled and stored in the application, Platform24 has chosen to target adherence to level 3 requirements as mandated by ASVS. 

The Platform24 architecture and services are built to be highly scalable and performant and have been load-tested to handle sustained traffic of 240,000 concurrent users and peaks of 300,000 concurrent users.

Platform24 Healthcare AB is also certified according to ISO 14001, ISO 27001, ISO 13 485 and the Dutch standard NEN 7510.

Our Whistleblowing service

We value an open and responsible company culture with strong ethical standards. Our whistleblowing service makes it possible to report suspicions of serious malpractice safely and, if needed, anonymously via an external confidential channel.