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.
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.
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.
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.
Our engineering team is specialized in agile development of native mobile, desktop and web applications with strict regulatory requirements.
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.
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.
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.
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 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.
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.
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