SaMD, DTx digital health innovation in life sciences
SaMD, DTx digital health innovation in life sciences
Empowering 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
Together with our partners, our team conducts workshops during the discovery process. Our collaboration lasts the entire time. Every project starts and finishes with the needs of the product users and the business cases of our partners.
User research, validation
We consider the opinions of patients and product users while making decisions. Unmet demands are revealed and vital validation and feedback are provided by regularly involving end users and gathering human insights through user research.
Human-centric design
All fields are covered by our incredibly talented design team. They have mastered the difficulties of balancing stringent rules and a stunning product, fusing patient needs with intuitive and user-friendly design to produce a remarkable end result.
Develop, deliver
Develop, deliver
Regulatory experts
The cornerstone of Spectre Technology’s identity is patient safety. As rules are implemented, we make sure that every digital health product meets the standards before it is released into the market.
Software development
Agile development of native desktop, mobile, and web applications is our area of expertise. Our product design and engineering teams work together to create outstanding regulated digital health products.
Leading quality
The foundation of our procedures is quality assurance. Our ISO 13485:2016 certified Quality Management System enables us to create, manage, implement, and update SaMD and DTx software solutions.
Launch, evolve
Launch, evolve
Product release
Regulations and localization can get more complicated when a product is released in several markets. We guide you through the legal and regulatory requirements, assist you in prioritizing markets, modify your company to support the digital product, provide papers for approval, and help you choose the best channels.
Data insights
We track user interaction and performance with each feature once your digital product is released into the market. With a data-driven approach, we can collectively improve on version 1 and continue to learn about user behaviors by knowing how your digital health product functions in the hands of its intended consumers.
Version evolution
The initial product version is precisely that—the initial one. We keep refining the user experience by testing the product with actual users to have a better knowledge of their requirements. This knowledge enables us to create products that can effectively alter patient behavior in order to enhance their quality of life.
Maintain, nurture
Maintain, nurture
Operations, maintenance
Under ISO 13485:2016-certified QMS, our operations team proactively and continuously monitors your applications for events or modifications that may affect the security, validated state, or user experience of your digital health products.
Hosting, monitoring
We manage GDPR and HIPAA-compliant cloud hosting infrastructures in collaboration with Microsoft. We provide SaMD-ready cloud solutions with our certified Azure platform that interfaces with web and mobile-based applications.
Decommissioning
Regulators and inspectors are starting to worry more about safe and thorough decommissioning. Together with our clients, we guarantee managed decommissioning of apps and data, which includes delisting medical devices with regulatory bodies.
Other services
Other services
We prioritize developing the knowledge and skills of our RA/QA and medical affairs team while assisting and advancing the larger life sciences ecosystem through collaborations, events, and mentoring.
Quality Assurance
Medical device companies trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our global experience working with regulators and Notified Bodies. Read More
Regulatory, Medical Affairs
An accredited medical and regulatory affairs partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). We deliver expert guidance from the initial design phase to the final stages of commercialization, publication planning, and ensuring compliance with all relevant regulations. Read More
Quality Assurance
Medical device companies trust us to meet or exceed the QA standards of EMA, FDA, MHRA, and other regulatory agencies. You can navigate the procedures for medical device product review, approval, and regulatory compliance with the support of our global experience working with regulators and Notified Bodies. Read More
Regulatory, Medical Affairs
An accredited medical and regulatory affairs partner providing consulting services for the complete lifecycle of medical devices and in vitro diagnostics (IVDs). We deliver expert guidance from the initial design phase to the final stages of commercialization, publication planning, and ensuring compliance with all relevant regulations. Read More