Our Approach
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.
Discover
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
prototyping
challenge and technology discovery
regulatory strategy
Define
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
Develop
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.
design
prototype
verification and validation
design documentation
regulatory submission support
Deliver
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.
