Digital health solutions for chronic disease patients
Digital health solutions for chronic disease patients
Empower medical device innovation with an experienced team. We bring technical, quality and regulatory expertise to support you from product ideation all the way to final submission.
Discover, design
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, 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
Develop, deliver
Regulatory experts
Patient safety is the foundation of who we are at Spectre Technology. We ensure that every digital health product complies with the necessary requirements, delivered to market through ongoing regulations.
Software development
We’re are specialized in agile development of native mobile, desktop and web applications. Our engineering team collaborate with product design to deliver amazing regulated digital health products.
Leading quality
Quality Assurance is at the core of our processes. With our ISO 13485:2016 certified Quality Management System, we can develop, operate, launch and maintain SaMD and DTx software solutions.
Launch, evolve
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
Maintain, nurture
Operations, maintenance
Our operations team continuously and proactively monitors your applications for incidents or changes that can impact the validated state, security, or user experience of your digital health products, all in line with ISO 13485:2016 certified Quality Management System.
Hosting, monitoring
Partnering with Microsoft, we operate GDPR & HIPAA-compliant cloud hosting environments. For digital products with regulatory requirements, we offer SaMD-ready Cloud solutions using our qualified Microsoft Azure platform that integrates with 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.