Quality & Test
Our extensive regulatory compliance expertise and lean ISO-13485:2016 certified processes help drive your medical product to a successful, first-time submission. We know what the FDA and international agencies look for and tailor the effort to your needs.
Here are some of the Quality services we provide:
- Authoring, contributing, and maintaining design history files
- V&V Planning to essential requirements and medical safety standards including protocol development, Ad Hoc testing, Unit Testing, Formal Verification, Verification Reports, and Coverage Reports.
- Navigating regulatory bodies including requirements review and regulatory strategy support (IEC-14971, IEC-62304, IEC-62366)
- Working with you directly to provide the right compliance information for your FDA submittal including 510(k) Clearance for a Class II device, a Pre-market Approval (PMA) for a Class III device, or a de Novo 510(k)
- Planning and strategizing the test plans and protocols for all disciplines including electrical, mechanical, software, usability, and systems; create, execute, and provide reports
- Defining systems and software to ensure the most rigorous treatment is limited to the safety-critical code
- Performing Gap Analyses for IEC-60601-1 for medical electronics, IEC-62304 for medical software, IEC 62366 for usability, IEC 61010-1 Safety Requirements for Electrical Equipment and other standards where needed
- Medical device quality assurance, medical device validation, and medical device compliance management
Point-of-Care Diagnostics Redefined
Sunrise Labs developed a bench-top diagnostic platform capable of performing laboratory-quality blood tests in minutes with untrained operators. By creating flexible electronics and software to manage disposable microfluidic cassettes, the device streamlined clinical workflows and enabled rapid expansion into new diagnostic applications.
Transforming Neuromodulation Therapy
Sunrise Labs helped a client evolve their neuromodulation device from a research prototype to a user-friendly product. By creating separate devices for home and clinical use, Sunrise ensured functionality across settings. FDA-approved and widely adopted, the devices support pain management, reduce opioid reliance, and enhance quality of life for diverse patient populations.
Strength through strategy
and transformation
Our agile project management is backed by years of experience across industry niches, revolutionary technologies, and organizations of all sizes.
Sunrise Labs doesn’t stop at the design stage. We are here to support your complete product life cycle.
Explore deeper insights on Quality & Testing
Check out our in-depth webinar recordings and articles to gain a better understanding of our approach to quality and testing for medical device product development.
Discover Our Full Range of Expertise
At Sunrise Labs, we specialize in Quality & Testing. But that’s just one part of the story. From concept development to clinical readiness, our expertise spans every stage of medical device and life sciences innovation.