Irwin & Associates  



Irwin & Associates, Inc. is a consulting firm comprised of medical device professionals who specialize in helping companies succeed. Everyone is too busy these days, and we want to help. Let us take that project or document off your hands and drive it to successful completion!

Our associates are able to quickly learn about your project needs and make a difference. We use engineering expertise along with thorough knowledge of regulations and expert writing ability to fill the gaps.

Irwin & Associates has years of experience in the medical device industry. Click here to learn more about how we can assist your team in the following areas:

  • Project Management
  • Quality Systems
  • Full Cycle Medical Device Documentation
  • Design Verification & Validation
  • Risk Management
  • R&D to Production Transfers
  • User Manuals and IFUs/DFUs
  • Microbiology / Sterilization Validation

We look forward to helping you succeed!

I&A Mission Statement
I&A provides superior support for the medical device industry by offering top-notch technical support, documentation and project management services. We deliver exceptional quality of work by our dedicated and knowledgeable engineers, who take pride and ownership in each project's success.