Our Approach

discover | Define | develop | deliver

The ISO 13485:2016 certified Sunrise System applies a top-down approach to fully understand your user and business needs to design the right solution. Our large multidisciplinary team stands ready to apply its unparalleled medical device development experience to drive your product to market quickly.


Sunrise reduces program risk early in the project lifecycle by combining a deep understanding of human behavior, technology risks, and worldwide regulatory requirements.

We help our clients to design the right product before developing it in the right process.

user-centered research


challenge and technology discovery

regulatory strategy


Backed by the research and a shared product vision from the discovery phase, we collaborate on design inputs to provide a solid foundation for medical device product development.

strategic systems approach

requirements and architecture

user experience and interactions

industrial design


All disciplines converge turning requirements, architectures, and concepts into integrated designs and refined medical device prototypes.

System Engineering and Program Management combined with continuous and iterative testing ensures the project stays on course. Our Agile methods identify and solve problems quickly.



verification and validation

design documentation

regulatory submission support


Our medical device commercialization team supports your final push to launch with deep expertise in transfer to manufacturing, design history file preparation, regulatory compliance, medical device quality assurance and management.

We are here to support the next steps in your product roadmap.

design transfer

manufacturing support

post launch support

Making lives better – one advancement at a time

Our development process drives MedTech innovation in devices ranging from complex electro-mechanical systems to digital health solutions for hospital, laboratory, and home use.

overhead shot of schematics