Compliance

MDR Certified Triage

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.

MDR-certified triage – How it works

With the certification, there will be a clear separation between the medical logic and the triage engine, where only the engine is defined as a medical device. This provides good opportunities for the customer to, as an alternative to the proposed logic, be able to independently adjust the medical content. It can be useful for instance to determine which combinations of which symptoms have the patient referred to a certain level of care, or to be able to more easily handle, for example, local variations in the business’s opening hours.

You can read more about triage under self-service and automation

In addition to Triage24, we intend to certify other medical device software products that are currently under development. We look forward to returning to you with more information about these.

Platform24’s triaging software achieves EU MDR certification

“MDR requires a higher level of “user-friendliness” in order to minimize health risks due to user misuse. Platform24 develops solutions that work not just for nisched groups, but for every practitioner and patient in a healthcare system. “

Jingcheng Zhao, Research and Real-World Data Manager

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.