Making mental health burdens visible
Summary
Klenico
To this day, psychiatric diagnostics relies largely on conversation and the clinician’s experience. Klenico makes this process structured, visual and comparable over time.
In the self-report, patients name their mental health burdens and rate their severity. The result appears as a symptom map, a visual overview of symptoms and symptom clusters. Healthcare professionals review this self-assessment in the clinical validation, assign diagnoses and derive the therapeutic focus. Repeated measurements make the course of treatment traceable. The product is in use in Germany, Switzerland and Austria.
Klenico is a Class IIb medical device under the MDR. QuickBird Medical took over the outsourced software-related activities from the previous service provider, adapted the software documentation and cyber security to the applicable MDR requirements and, as software service provider, accompanied Klenico through the conformity assessment procedure with the notified body. Since then, QuickBird Medical has been operating, maintaining and further developing the software part.
Challenge
Klenico was already on the market as a medical device under the former Medical Device Directive (MDD). With the transition to the MDR, the classification rises and Klenico falls into risk class IIb. This sharply raises the required level of evidence, for the medical device software as well as for cyber security.
With the higher classification, the software safety class under IEC 62304 also moved from A to B. This requires much deeper documentation and verification, down to the level of individual software units, and the evaluation of every anomaly including root cause analysis.
In cyber security, individual measures are no longer sufficient. The notified body expects consistent evidence of a Secure Development Lifecycle that is also reflected in the technical documentation of the medical device.
Process
Before the first day of maintenance came the migration: taking over the infrastructure, source code and software-related technical documentation and reviewing the existing code through code reviews. We then adapted and further developed the documentation in line with the requirements of IEC 62304 for safety class B: software requirements, architecture down to the level of software units, system and integration tests, configuration management and the evaluation of third-party components.
We set up cyber security as a separate track within our ISO 27001 certified information security management system and in line with MDCG 2019-16: security requirements and their verification, continuous monitoring of third-party components for known vulnerabilities, hardening of the infrastructure and an annual penetration test by an independent provider.
On this basis, we supported Klenico from the technical side in the conformity assessment procedure and, as software service provider, were also audited as part of the MDR certification audit. We prepared the software-related evidence for the notified body, answered its questions and implemented its follow-up requests. In ongoing operations, we work within our ISO 13485 certified quality management system, with fixed response times and second-level support for Klenico’s end customers.
Result
Klenico is successfully certified as a Class IIb medical device under the MDR. As the manufacturer, Klenico successfully completed the conformity assessment procedure with the notified body, and we accompanied the procedure on the software side. The software documentation meets safety class B under IEC 62304. Cyber security is also consistently demonstrated, and operations continued without interruption throughout the entire takeover.
For Klenico, this means one point of contact for the entire software part, while the team focuses on science, sales and supporting its customers.
“QuickBird Medical understands down to the smallest detail how to develop and safely operate regulated medical device software, even in higher risk classes of the MDR. The team manages a complex software landscape of web and backend components for us and ensures that everything runs smoothly and is always compliant with regulations. We have also benefited enormously from their expertise in the area of cyber security. We feel we are in very good hands in every respect.”
LAURA HENRICH
CEO of Klenico
Screenshots
For patients
For healthcare professionals
Future
We continue to support Klenico’s software and expand it step by step, from new features to the ongoing safeguarding of the product. In parallel, Klenico is expanding its offering and now serves not only clinics and practices but also insurers, employers and affected individuals directly.
More information on the official website: klenico.com
