Making lives better — one advancement at a time

Sunrise Labs delivers best-in-class medical device design and engineering expertise for all stages of product development. Our device design is inspired by passion and delivered with excellence.

Deep expertise is applied where you need it while employing optimized ISO-13485:2016 certified work processes. We identify and fill gaps in your program to provide the best solution for your project.

See how we have helped our clients in complex electro-mechanical, combination products, and life science instrumentation with end-to-end product development.

Explore successful partnerships with Sunrise Labs

be.well

Cloud-enabled, HIPAA-compliant app paired with an at-home infectious disease testing platform

See the Case Study

Syncardia Systems

Life changing Class III medical device driving an artificial heart

See the Case Study

Automated Osmometer

Automated, high accuracy sample testing for Pharma.

See the Case Study

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

Let our clients speak for us

“We could not have better, more collaborative and capable partners; and it shows in the work!”

Bill Skillman

President & CEO at Velico Medical, Inc.

I have been super impressed with the professionalism and delivery from you and your team in supporting the development and launch of the iOS-compatible SOZOapp.

Shashi Tripathi

CTO, ImpediMed, Inc

“Sunrise’s IEC-62304 expertise helped us to meet the EU Medical Device Directives in short order. Their responsiveness and professionalism is notable, and appreciated!”

Mike Ambrogi

COO, Novocure

“Sunrise was able to deliver on a complex project with an extremely challenging timeline. Crucially, the architecture they created on short notice has proven to be ideal in enabling future product development in addition to rapid time to market. The firm demonstrated an impressive understanding of the software and hardware requirements underlying a successful family of medical products.”

David Steinmiller

COO, Claros Diagnostics, Inc.

“We have enjoyed working with you all immensely, and are proud of what we have collectively developed. I’ve been very pleased with the expertise, depth, responsiveness, honesty and friendliness of the staff at Sunrise. You guys & gals have built a great company. Keep it up.”

Jeffery Cerier

Product Development, Momelan Technologies, Inc

“Gamma Medica’s LumaGEM MBI Solution is poised to revolutionize the battle against breast cancer by changing the outlook for women whose early stage tumors may go undetected or unconfirmed with a mammogram. Sunrise Labs expertise in system engineering, software architecture and Quality Management contributed to the success of the LumaGEM and ensured that future product offerings will pass IEC 60601, 3rdEdition’s testing, documentation and certification with ease.”

Jim Calandra

President & CEO, Gamma Medica

“We worked with Sunrise Labs over the course of a year to design an electronic (with software), class II medical device. Bottom line, they delivered on commitments. I was very impressed with the Sunrise team’s technical skills, level of design experience, their unwavering commitment to respond to our needs, and the project leader’s wisdom and leadership skills. Together, we produced a product that sailed through FDA review and delivered 100% functionality in clinical studies.”

Mike Barsness

Senior Director of Engineering, Transport Pharmaceuticals, Inc.

“Our initial engagement with Sunrise was a design review of a critical analog section of our device. Their suggestions resulted in significant improvements in performance. We then asked them to take on a larger role, including redesign of a complex digital board and embedded software development, adding new capabilities to our device design. These were both handled professionally and efficiently. Their engineers were also invaluable as we encountered integration issues with OEM components, working as part of our multi-country team to identify root causes and implement effective solutions.”

Neil S. Rothman, Ph.D

Executive Director, Product Development, BrainScope Company, Inc.

“Sunrise Labs is dependable, competent, experienced, and well managed.”

Stephen R. Teta

Director of Sustaining Engineering, Instrumentation Laboratory

We are ready for you

Let us help you solve critical challenges to change people’s lives. Partner with our team of experts passionate about applying technology to improve lives.