Our process

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.

A process for exceptional outcomes

Our approach to product development is led by collaborative innovation. Unique, beautiful and designed for patient outcomes, The Dawn Platform delivers safe, regulated products for those that need them.

Customer deep dive

The business case of our partners and end users are the focal core of every project. Our extensive expertise allows us to challenge and inspire strategic direction within digital health product development.

User research and validation

For a product to be truly great, it must be built on a solid foundation of insights. We ensure this throughout the discovery, design and development phases, by continuously including end-users to provide validation and feedback.

Digital product design

Our highly skilled and experienced 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.

Regulatory affairs

Your digital health product may be subject to medical device or GxP regulations, which means specific requirements on how the product is developed, documented, and approved. We make sure your digital product complies with applicable regulatory requirements.

Software development

Our engineering team is specialized in agile development of native mobile, desktop and web applications. These come with strict regulatory requirements, but they've got that covered.

Quality assurance

Our Quality Management System is anchored in every part of our company 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.

Product release

We help you prioritize launch markets and adapt your global organization to support your digital products. We provide the necessary documentation for approval of labeling material and submission to ethical committees and help you produce compelling, localized presentations in mobile app stores.


User acquisition

We help you navigate the often complex legal and regulatory requirements, identifying the right channels for you to promote your products.

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 and monitoring

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

About NMA

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

Our reliable digital health solutions are developed and operated based on knowledge within industry best practices, and adhere to the following standards based on our customers’ 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.

Excellence through technology

Our areas of expertise span a wide range of disciplines, meaning we have the skills to develop solutions across fields and disease areas. Diversity in our people's skills, personality and nationality are the cornerstone of our budding innovation environment.
Mobile apps (iOS & Android)
Azure Cloud
Connected medical devices

Looking to build innovative products?

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