Our team builds digital health products that can be used instead of conventional drug therapies, offering entirely new and alternative approaches to improve the quality of life for all chronic disease patients. We can act as legal manufacturers of medical devices and IVDs.
Our expertise
Our expertise
Medical device innovation with an experienced team that brings technical, quality, and regulatory expertise to support you from SaMD, and DTx digital health product ideation, up to final EU MDR, FDA, or other regulatory submission.
An accredited RA/QA partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). Our team delivers expert guidance from the initial design phase through to the final stages of commercialization, ensuring compliance with all relevant regulations and quality standards. Find out more
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. Find out more
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. Find out more
Medical device manufacturing
Medical device manufacturing
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.
Our expertise ensures compliance with the ISO 13485:2016 medical devices standard to guarantee the highest quality of our services.
Our expertise ensures compliance with the ISO 13485:2016 medical devices standard to guarantee the highest quality of our services.