Building the future of digital health

We collaborate with our partners throughout the entire process, with regular workshops led by our expert team taking place during our discovery phase. The business case of our partners and the product users are at the core of every project.

The patients and users of our products guide every decision we make. Uncovering human insights through user research and continuously including end-users provides essential validation and feedback, as well as understanding the unmet needs.

Our highly skilled design team cover all disciplines. They master the challenges that come with balancing strict regulations with an outstanding user experience and beautiful product, combining patient needs with intuitive user experience to deliver exceptional design.

Patient safety is the foundation of who we are at Dawn. Our Platform is built on regulatory standards, meaning we ensure that every product complies with the necessary requirements, delivered at an accelerated speed to market through ongoing regulatory automations.

Our leading engineering teams are specialized in agile development of native mobile, desktop and web applications. With experience in navigating the complex regulatory space, they collaborate with product design to deliver beautiful, regulated products at speed.

Our Quality Management System is anchored in every part of Dawn Health, and Quality Assurance is at the core of our processes. With our ISO 13485:2016 certified QMS, we can develop, operate, launch and maintain SaMD and GxP software solutions.

Releasing across multiple markets can bring complexity with regulations and localization. We help you prioritize markets and adapt your organization to support the digital product, providing documentation for approval as well as navigating the often complex legal and regulatory requirements, identifying the right channels for you to promote your products.

Once your digital product enters the market, we monitor the performance and user engagement with each individual feature. Understanding how your digital health product performs in the hands of its intended users enables us to collaboratively iterate on version 1 and continue to learn about user behaviors, all with a data-driven approach.

The first product version is just that, the first. We continue to improve the user experience, testing the product with users in the real world to continue building a deeper understanding of their needs. This understanding empowers us to develop the product capabilities to deliver the behavior change that’s needed to improve the lives of patients.

Our Operations Team continuously and proactively monitors our applications for incidents or changes that can impact the validated state, security or user experience of your digital products, all in accordance with our ISO 13485:2016 certified Quality Management System.

Through our Microsoft Partnership, we operate GDPR & HIPAA compliant cloud hosting environments. For digital products to with regulatory requirements, we offer SaMD and GxP ready Cloud solutions using our qualified Microsoft Azure platform, that seamlessly integrates with mobile and web based applications.

Secure and complete decommisioning is increasingly becoming a concern of regulators and inspectors. In agreement with our customers, we ensure a controlled decommissioning of data and applications, including delisting of medical devices with regulatory authorities.