Medical Device Development Consulting for Over 30 Years

Founded in 1992, Sunrise Labs has grown to be one of the most highly regarded medical device design companies. For over 30 years we’ve helped clients turn ideas into commercial medical devices by leveraging our team of talented medical device designers, systems engineers, software and electrical engineers, mechanical engineers, regulatory advisors, and project managers. We have extensive experience bringing class II and class III medical devices to market. Classify Your Medical Device

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Our Medical Device Development Process

Our extensive experience in medical device design, cutting-edge technologies, and working with organizations of all sizes enables us to offer reliable and agile product development services. Our commitment to your success doesn’t end with design – we provide comprehensive support throughout your entire product life cycle. Let Sunrise Labs be your trusted partner in bringing your ideas to market.

We break our medical device development process into four stages:

Discover -> Define -> Develop -> Deliver. 

Sunrise reduces program risk early in the development process by leveraging our expertise in human factors, technology risks, and global regulatory requirements. Our services aid clients in designing the optimal product and developing it utilizing industry best practices. Partnering with Sunrise safeguards program success from the outset.

The ISO 13485:2016 certified Sunrise System utilizes a top-down approach to gain a thorough understanding of your user and business needs. Our team is equipped to apply their extensive medical device experience to guide the development of your product to market quickly.

Backed by research and a unified product vision established in the discovery phase, we work together to provide well-informed design inputs that serve as a sturdy foundation for the development of your product.

Our diverse disciplines merge to craft integrated designs and prototypes, starting with requirements, architectures, and concepts. By implementing a combination of System Engineering and Program Management with continuous, iterative testing, we keep projects on track. Our Agile approach enables swift problem identification and resolution. You can trust us to deliver efficient and effective solutions.

The Sunrise Labs team is fully equipped with extensive expertise in transfer to manufacturing, Design History File preparation, regulatory compliance, and Quality Management to assist you in the final push toward launching your product. Plus, we stay connected to guide you through the next steps in your product roadmap.

For more information, read our blog post on The 5-Step System Engineering Process

Medical Device Areas of Expertise

Full Product Development

Broad and deep in-house engineering expertise spanning user research through manufacturing prototypes to design transfer

User-Centered Design

We solve challenging patient & user-centered problems in medical device design and connected health that don’t have clear precedents to follow

Systems Engineering

With deep expertise in architecting products that require fail-safe or fault-tolerant operation, our Systems Engineers design solutions that work

Clinical Builds & Design Transfer

Developing products from initial concept and prototyping through transfer to manufacturing

Designed and Developed with Sunrise

Explore our innovative solutions for smart products that improve our world


ISO-13485:2016 certified work processes. Let our work speak for us. Read our most recent client case studies.

Our Team of Medical Device Designers & Developers

We attract and retain highly skilled engineers who are passionate about bringing your ideas for improving lives to market. We are extremely proud of the Sunrise Labs team built of industry-leading minds.

Privately held and operated, Sunrise Labs was founded in 1992. Clients leverage the extensive knowledge of our 125+ talented designers and engineers for their product development needs.

Our Core Values

Engineering excellence

We love what we do, we stay current, and we do it right! Our team is passionate about applying technology to improve lives.


We do what we say we will do and we stand behind our work. Over-delivering trumps over-promising.

Respect for people

We assume positive intent from all of our associates and clients and inquire directly when we don’t understand someone’s actions.

Continuous improvement

We define our processes, measure results, learn, and improve to optimize quality, cost, and delivery.

Latest Insights on Medical Device Design & Development

Systems Engineering for Medical Device Development

This whitepaper outlines how systems engineering can contribute to achieving greater success in completing complex…

Electronic Implantable Medical Devices

Developing Implantable Medical Devices

This webinar focuses on these benefits and solutions to the concerns that arise when developing an electronic implantable…

Artificial Intelligence & Machine Learning

Leveraging AI & ML in Medical Products

Some challenges and considerations related to product architectures that might include Machine Learning

Join the Sunrise Team

If you are looking to work alongside creative problem solvers in a collaborative work environment while helping clients transform their visions into life-changing products, we invite you to apply to Sunrise Labs.