Building the future of digital health

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.

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.

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.

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.

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.

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.

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 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 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.