Our objective is to build digital health products that center around people, making them more accessible, and empathetic. We improve the life quality for chronic disease patients by building regulated digital health products.
Our expertise
Our expertise
Our expertise in building regulated digital health products, specializing in SaMD and DTx, is trusted by industry leaders. By maintaining the highest standards of quality and innovation, we bring technology expertise and healthcare industry know-how to solve real human problems.
We specialize in creating software solutions that are compliant with the highest medical standards and focused on SaMD. Our approach integrates cutting-edge technology with deep clinical insights to ensure that each SaMD product we develop is not only regulatory compliant but also delivers impactful health outcomes. Our expertise lies in transforming complex medical needs into user-friendly digital solutions, paving the way for a new era in healthcare technology.
We design DTx solutions that go beyond providing just digital tools. Our treatment modalities are tailored to treat, manage, and prevent a wide range of medical conditions. Each DTx product is carefully crafted by blending medical expertise with digital innovation to provide evidence-based therapeutic interventions. Our commitment is to deliver DTx that adhere to clinical standards while improving patient outcomes.
We develop, operate and maintain all projects in compliance with our ISO 13485:2016 certified QMS. Our team can qualify and develop both medical technology products and services in accordance with IEC 82304, IEC 62304, ISO 14971 and GAMP 5 – all processes that further secure the ability to provide high-quality product development that meets requirements for time and budget.
Process
Process
We've developed an approach in four phases to deliver digital health products that align perfectly with your vision and exceed your expectations.
This phase includes a collaborative approach with partners, focusing on their business case and product users. It involves user research and validation, guided by patient and user feedback to understand unmet needs. The human-centric design process is undertaken by a skilled team that balances regulatory requirements with an exceptional UX.
This stage involves regulatory expertise, ensuring each product complies with the necessary requirements. SaMD & DTx product development is conducted by agile teams specialized in native mobile, desktop, and web applications. Quality is our core focus, with an ISO 13485:2016 certified QMS in place for developing, operating, launching, and maintaining software solutions.
Services include assistance with product release across multiple markets, addressing the complexities of regulations and broader needs. We also support user acquisition, helping to navigate legal and regulatory requirements and identify promotion channels.
This phase involves continuous monitoring of applications for incidents or changes impacting the product. Hosting and monitoring services are provided through GDPR & HIPAA-compliant Microsoft Azure cloud environments. In line with our clients’ needs, we guarantee a managed decommissioning of data and applications, which encompasses the removal of medical devices from regulatory bodies’ lists.
Should we collaborate?
Should we collaborate?
We can help you as your essential supplier and collaborator in the journey of software certification. Our ISO certification signifies the quality and precision of our processes. Our team is already familiar with the nuances of digital health development in the healthcare sector, including documentation procedures.
The greater our involvement in the process, from the design phase through to implementation, the more we can assist in preparing the necessary documents for certification, either independently or in collaboration with you.
Our software development approach is guided by agile methodologies, which provide flexibility and allow us to adapt quickly to changes. At the same time, we are committed to adhering to the IEC 62366 and IEC 62304 standards, which are essential for ensuring that our products and processes meet the highest international requirements for medical device software development and usability engineering. By focusing on both agility and compliance, we deliver software solutions that are not only user-friendly and efficient but also fully compliant with critical industry regulations.
Our team specializes in implementing and utilizing the HL7 FHIR standard. We do this by developing and integrating FHIR-compliant systems that ensure secure and efficient data exchange. Our solutions are tailored to meet the specific healthcare organizational needs of healthcare providers, payers, and IT vendors. Our expertise is crucial for those seeking to enhance their healthcare data management and sharing capabilities in a standardized and efficient manner.
Your digital health project is in the hands of a project manager who has significant experience in managing and guiding projects. This professional has a wealth of knowledge and expertise, which ensures that the project is conducted efficiently, meets its objectives, and navigates the digital health technology complexities.
Our team doesn’t just focus on coding and technical aspects; they understand the profound impact their work can have on people’s lives. Each line of code they write and every software solution they develop is done with the awareness that it has the potential to save lives. This sense of responsibility and dedication forms the foundation of their approach to digital health development. They blend their technical skills with a humanitarian mission, emphasizing their critical role in advancing healthcare outcomes and patient care.