Building the future of digital health

With our all-in-house, collaborative approach, we deliver products of the highest quality out to market at exceptional speed.

Discover & Design

Customer deep dive

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.

User research and validation

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.

Human-centric design

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.

Develop & Deliver

Regulatory experts

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.

Software development

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.

Leading quality

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.

Launch & Evolve

Product release

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.

Data insights

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.

Version evolution

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.

Maintain & Nurture

Operations & maintenance

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.

Hosting & monitoring

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.

Nordic Medtech Alliance

Nordic MedTech Alliance (NMA) is a strategic alliance between three of the leading MedTech developers and consultancies in Northern Europe.

TPU, Prevas & Dawn Health

NMA is a fully-fledged and end-to-end MedTech consultancy, accelerating development of IoT-enabled digital health products. Combined, NMA has a workforce of over 1.600 employees, with deep vertical capabilities across all areas of product and software development targeting the healthcare industry.
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Standards and certifications

Everyday at Dawn Health is underpinned by patient safety. Our solutions are developed and operate based on industry best practices, adhering to the following standards based on our pharma partners’ needs.
ISO 13485:2016

Quality Management for Medical Devices

This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry. Safety and quality are non-negotiable – that’s why Dawn Health is certified to 13485:2016.
ISO 14971

Application of Risk Management to Medical Devices

Risk Management is an integral part to Dawn Health Quality Management System. The standard describes the processes for identifying the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
IEC 62304

Medical Device Software Lifecycle Processes

Our quality management system implements IEC 62304 as a framework throughout the software life cycle processes.
ISO/IEC 27001

Information Security Management

Our information security management is based on the ISO 27001 principles and ensures the security of information assets whether in-house or entrusted to us by our customers.

A risk-based approach to compliant GxP Computerized system

ISPEs GAMP5 provides a product lifecycle framework and best practices for GxP critical computerized systems in the pharmaceutical industry. Our QMS leverages the ISO 13485, IEC 62304, ISO27001 and ISO 14971 standards to implements GAMP5.
IEC 82304

Health Software Product safety

The standard applies to the safety and security of stand-alone health software products and points to ISO 14971 and IEC 62304 for risk and SW lifecycle processes. Applies to both MDSW and other health software products.
IEC 62366

Medical Device Usability

Relevant parts of the standard are used during risk management activities and UI/UX design.

Software cybersecurity

This standard addresses cybersecurity for connected devices and DH follows this standard to address product specific cybersecurity risks. It is recommended to always take cybersecurity risks into consideration.