We are here to assist you with your Medical Device needs.

IRC serves the Medical device community to assist with the rigorous process of quality management, testing and preparing the documentation to submit to the FDA for clearing a Medical device to sell in the US market. IRC’s expert engineering staff and partner testing labs have the experience and knowledge to guide you through the entire process. We offer professional services in Shanghai, China and the United States.

What we do

International development and marketing of medical devices is a highly regulated process that requires expert level navigation to prevent bottlenecks and minimize risk. IRC specializes in providing this advanced regulatory consulting expertise to the Medical Device industry.

Your Partner in FDA Compliance

  • FDA 510(k) Document Creation and Submissions
  • Testing and Validation Assistance
  • Medical Device Concept Assistance
  • Quality Systems Audits and Set up
  • Post Market Issues
  • US Agent Services
  • Technical Affairs
  • Regulatory Assistance