Services

Discover, Define, Design, Deliver

Sunrise Labs is focused on making our clients successful. We deliver extensive medical device design and engineering expertise for all stages of product development, using optimized ISO-13485 certified work processes. Our extensive engineering spanning software, electrical, systems, and mechanical, coupled with over 25 years of experience yields strong and robust solutions for our clients.

Our product development services include:

Engineering & Design

Our expert systems, electronics, software, and mechanical engineers have decades of experience developing FDA regulated devices and consumables. We're constantly evaluating the latest available technologies to apply to our client's design challenges. From the latest low-power microprocessors and Bluetooth transmitters, to the latest cross-platform software development to rapid prototype techniques -- Sunrise is at the vanguard of innovative product development.

Quality & Regulatory

Through years of experience, we understand the needs based on device class and software safety to tailor development processes in appropriate documentation and testing is completed to meet FDA requirements.

Manufacturing Transfer

Medical device manufacturing has unique challenges from a regulatory and quality standpoint. Sunrise's well developed process to guide transition of designs into manufacturing begin with early engagement with trusted partners.

Product LifeCycle Support

Product launch is just the start of the product lifecycle -- market needs are constantly evolving, and new product requirements may result from obsolete parts or changing regulatory standards. Sunrise provides product lifecycle management and maintenance needed to meet market and client demands.

Consulting

Sunrise offers holistic solutions with the focus of enabling product launch. Consulting services include technology readiness assessments, design reviews, 60601-1 4th edition assessments and assistance, gap analysis for quality systems, and software development process reviews.

Project Rescue

It happens -- your development project gets off track resulting in rising costs and delayed schedules. Sunrise Labs' Project Rescue gets your development project back on track with lower risk and higher confidence by providing corrective measures using a disciplined systems approach.