Quality and Regulatory

Developing Strategies for Regulated Medical Devices and Life Science Instrumentation

The landscape of regulations is continuously chaning, driven by new technologies and new market requirements. Failure to meet these regulations may prevent the product from entering the market. Our clients leverage our extensive regulatory expertise and lean ISO-13485 processes to usher their product on a successful approval path.

Design Controls

Using thorough design control processes, we help our clients achieve rapid approvals by addressing potential root causes of readmission, which can cost critical market launch delays. Sunrise's design controls processes include:
  • Design and development plans
  • Design inputs
  • Gap analysis
  • Risk and Hazard Analysis
  • FMEA
  • Formal Design Reviews
  • Drawings and Specifications
  • Software Development Processes and Documentation
  • Change Control
  • Design Transfer

Verification and Validation

Our verification and validation team specializes in making medical devices compliant. Using a repeatable and proven process, we are able to engineer a path toward targeting a successful submission for the first time. Sunrise has a strong understanding of device and software safety class to meet FDA requirements.