The business case of our partners and the product end users are the core of every project. It’s an essential part of our process that we collaborate with our partners throughout, with workshops taking place throughout the discovery phase.
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 broader needs. We help you prioritize launch markets and adapt your global organization to support your digital products, providing the documentation for approval and help you produce compelling, localized presentations in mobile app stores.
Every product we create with our partners is designed to improve the lives of patients, so getting it into their hands is vital. We help you navigate the often complex legal and regulatory requirements, identifying the right channels for you to promote your products.
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.