Services

Full stack digital health consultancy

We help our clients and partners get the most out of digital health - starting with ideation to solution development, regulatory approval, and life-cycle management.

Business development

The business case of our customer is at the core of all projects and our extensive expertise allows us to challenge and inspire strategic direction within digital health product development.
 

User research and validation

Every great product is built on a solid foundation of insights. During the discovery, design, and development phases we always aim to include end-user as much as possible for constant feedback and validation.

Digital product design

Our experienced design team cover all digital design disciplines with a flair for the regulated playing field and human-centered mindset to creating outstanding and intuitive products. 

Regulatory affairs

Your digital health product may be subject to medical device or GxP regulations which puts strict requirements to how the product is developed, documented, and approved. We make sure that 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 with strict regulatory requirements.

Quality assurance

Quality Assurance is at the core of our processes and with our ISO 13485:2016 certified Quality Management System we can develop, operate, launch and maintain Software as a Medical Device and GxP critical 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 legal and regulatory requirements and identify the right channels for promoting your products. Online advertising, HCP/KOL endorsement and social media are among the tools we can leverage to ensure your products find your patients and providers.

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.

Decommissioning

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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We also take care of regulatory affairs and quality assurance

Do you have all the great ideas and abilities to build, but lack the know-how of what it means to develop medical device software (MDSW) and bring it to the market? Let us help you out – we’ll oversee and advise you throughout the process.

 

Our expertise

  • Quality Management
  • Risk Management
  • MDSW Safety
  • Information Security Management
  • MDSW Lifecycle Management

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.
GAMP5

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.
UL-2900-2-1

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, making it possible to develop solutions across fields and industries. Diversity in skills, personality, nationality, and views is the cornerstone of our budding innovation environment.
Mobile apps (iOS & Android)
Web
Azure Cloud
Connected medical devices
CMS

Looking for help on digital solutions?

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