Building the Healthcare of Tomorrow Today, Together.
We partner with SMEs in the Digital Health sector, focusing on three main areas – Empowering the Organization, Turning Ideas into Reality, and/or Growing their Digital Health Business.
We focus on what really matters – Innovation and Patient Care.
We build, modernize, and empower digital health solutions through design thinking, agile development, and targeted training.
Build your Digital Health Idea
- Focus on identifying user needs and safety through design thinking.
- Feasibility and risk assessment, fast prototyping and collection of design inputs through design sprints.
- SW development with compliance and agile SW Lifecycle with regular demonstration of the progress.
- User Interface and Usability Evaluation, Design Transfer, Audit and Certification support.
Modernize your Digital Health Solution(s)
- Assess the legacy system's technical debt, UX flaws, and interoperability gaps.
- Create a system modernization plan using latest health IT standards.
- Use agile methods to modernize the system by developing interoperability, updating architecture, and redesigning the UI.
- Deploy the modernized system, provide user training, and support for audit.
Empower your HealthTech Organisation
- Competency assessment and skill gap analysis.
- Targeted training and continuous education.
- Knowledge sharing based on hands-on experience.
- Performance monitoring and feedback sessions.
- Empowerment and ownership.
- Increase productivity and enhance performance.
With our support, discover how we innovate in SaMD, AI management systems, Heart disease diagnostic software, and Agile project management to transform medical and IVD device development and compliance.
SaMD SW Lifecycle Process
Quaregia addressed SaMD development gaps by creating an Agile Software Lifecycle blueprint, integrating Bitbucket, Jira, and Confluence, aligned with IEC 62304 and AAMI TIR 45, in collaboration with Innosuisse over six months.
AI SaMD Management System
Quaregia aimed to coach customers in obtaining CE markings for AI Medical Devices by establishing a scalable AI/NK Management System aligned with GMLP, EU AI Act, and ISO 42001:2023, over 3 months.
Cardio Explorer v2
The Cardio Explorer v2 project aimed to enhance CAD diagnosis software by improving interoperability and compliance, integrating with Roche, and resolving Major Non-Conformities over six months.
Agile Project Management Office
Exscientia streamlined AI Pharmacoscopy Medical Device CE-mark under IVDR by establishing a QMS, Application Lifecycle Management, and an Agile Project Management Office over 13 months.
IVDR Assistant Product/Market Fit
Platomics GmbH streamlined the CE-marking process for IVD Medical Devices under EU IVDR by transforming 95% of the pathway, involving an innovation task force to develop an MVP, business model, and investor pitch deck over 12 months.
PlatoX Lab IVD
Platomics GmbH created PlatoX LAB IVDR, a software service for human germline genetic testing. It analyzes DNA data from sequencers to find genetic variants. We managed the development process, ensuring compliance with IEC 62304, IEC 62366, and ISO 14971 standards. The project took about 38 months.
As a Digital Health Lab, we continuously learn from our customers needs and drive the digitalization of our services, developing innovative products that support and fulfill those needs.
enMedD Design System
enMedD Design System enhances patient safety and user experience by simplifying processes and reducing use errors through intuitive and risk-based design.
enMedD CHP
A revolutionary Health LLM platform that seamlessly integrates health system's data without disrupting the system, ensuring highest accuracy using a proprietary appraoch, and simplifying compliance through CE marking
