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Medical Device Development

For over 30 years Suntra MedTech Solutions has been the leader in Medical Device Development. We've helped clients turn ideas into commercial medical devices, bringing both class II and III medical devices to market.

Medical device development consulting for over 30 years

Founded in 1992, Sunrise Labs DBA Suntra MedTech Solutions, 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 including 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. 

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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 Suntra MedTech Solutions be your trusted partner in bringing your ideas to market.

Suntra MedTech Solutions 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 Suntra 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 Suntra MedTech Solutions 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.

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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, Suntra MedTech Solutions, originating as Sunrise Labs, was founded in 1992. Clients leverage the extensive knowledge of our 125+ talented designers and engineers for their product development needs.

Suntra MedTech regulatory strategy and QA support

Have a medtech challenge? 
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Whether you're exploring a concept, scaling your roadmap, or need to build your team's capabilities, we’re ready to help.

Our medical device consulting services can help with:

Assessment/validation

We want to be sure you have done the technology readiness, risk mitigation, and requirement management needed to be successful. We help you identify 'what you didn't know, you didn't know'.

Clinical insight integration

Collaborating with physicians and care teams to ensure products solve real-world problems.

Competitive analysis

Validating that your product meets an unmet clinical need and is positioned for adoption will help you accelerate time-to-market and time-to-money

Cyber risk assessment

Ensuring products are intuitive, safe, and effective in real-world clinical and patient environments.

Cybersecurity

Guiding companies in safeguarding their systems, intellectual property, and operations against evolving and increasingly complex cyber threats.

Design prototyping

Developing concepts into functional prototypes that can be tested, refined, and validated.

Early stage tech assessment

We distill decades of medtech experience into practical applications and advice to help early-stage teams accelerate development, avoid common pitfalls, and move forward with greater confidence and clarity.

Manufacturing & scalability

Designing with production in mind to streamline transfer into manufacturing and reduce cost-of-goods.

Next-generation concept development

Anticipating how healthcare delivery is evolving and aligning solutions with tomorrow's needs.

Program management & planning

Establishing milestones, timelines, and resource plans that keep your project on track.

Regulatory strategy & compliance planning

Anticipating FDA and compliance requirements, we align product development with evolving standards to accelerate approvals and reduce costly delays.

Risk assessment

Identifying and addressing potential design and development challenges early, reducing costly delays and ensuring project success.

Staffing & skills assessment

Helping you identify the teams, tools, and processes to institutionalize innovation into your culture.

Systems engineering

Integrating mechanical, electrical, and software systems into cohesive, reliable solutions.

Technology scouting & integration

Identifying and applying cutting-edge tools, from miniaturized sensors to cloud-based platforms.

Verification & validation

Ensuring your device performs as intended, meets regulatory standards, and aligns with user requirements

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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.

Integrity

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.

Medical device areas of expertise

Full product development

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

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

Developing products from initial concept and prototyping through transfer to manufacturing
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Designed & developed with Suntra

Explore our innovative solutions for smart products that improve our world
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Results

ISO-13485:2016 certified work processes. Let our work speak for us. Read our most recent client case studies.
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Custom Medical Device Development & Innovation Consulting

Let’s operationalize your ideas.

Contact us today to set up a consultation and learn how our medtech consulting expertise can strengthen your strategy and accelerate results.

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