Sunrise Labs, founded in 1991 by MIT engineers, understands what it takes to turn innovative ideas into commercial medical devices. Clients leverage our extensive knowledge of key technologies and regulatory requirements to solve their design challenges. At Sunrise, our projects are more than just “a job.” Our team is passionate about improving patient outcomes, and helping our clients to succeed.
ISO 13485 Certified Medical Product Development
Apply Sunrise’s ISO 13485 certified process to ensure compliance with regulatory bodies worldwide. Sunrise offers a broad set of services to solve your challenges across the product lifecycle. From full product development (Concept to Launch) to subsystem development, we deliver clean sheet designs or design updates. Clients appreciate our flexible service offerings including independent design reviews, system engineering, electronics design, software development, SW verification and validation, documentation and testing, design for manufacturing (DFM), transfer to manufacturing, and post launch design maintenance.
Engineering and Design
While Sunrise provides complete product development, we can also help you deliver subsystems and technologies that integrate efficiently and effectively with your overall delivery. We work with you to understand your needs and develop a customized set of skills and processes that are best designed to integrate with your delivery process and team. Leverage our deep systems, electronics, software, and imaging expertise to augment your team.
Verification & Validation (V&V)
Meet FDA requirements for verification and software validation using Sunrise’s quality management system, testing expertise, and tools. Our focus is First Pass Compliance to remove delays and extra effort required for resubmissions by doing it right the first time.
Product Lifecycle Support
Solve your field issues and on-going manufacturing issues such as part obsolescence and regulatory compliance (60601-1 3rd Edition, RoHS, etc.). Markets and technologies are dynamically changing. Sunrise can help you navigate these changes, and keep your product portfolio shipping.
Leverage our extensive background and deep technical expertise to solve complex problems to yield innovative solutions. A Technology Readiness Assessment can prove invaluable to uncover potential issues early before you move from prototype to Commercialization.
Get your project back on track no matter where you are in the product development cycle. Our system approach to trouble shooting and product development expertise has been proven successful to get projects back on track.