We help you achieve compliance for your FDA and European MDR clearances. Sunrise Labs' nimble ISO-13485:2016 certified quality management system can be customized to integrate with your processes.
Our experienced team:
- Uses repeatable and proven processes to engineer your path to a successful first-time regulatory submission
- Works with you to provide the right compliance information for your FDA submittal. Whether a 510(k) Clearance for a Class II device, a Pre-market Approval (PMA) for a Class III device, or a de Novo 510(k)
- Articulates the final package for regulatory body submission at the beginning of the project
- Plans and strategizes the test plans and protocols for all disciplines including electrical, mechanical, software, usability, and systems; create, execute, and provide reports
- Defines and architects systems and software to ensure the most rigorous treatment is limited to the safety critical code
- Assesses when to run manual tests and when to perform automated testing
- Performs 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