Irwin & Associates, Inc.

irwin & associates, inc. is a consulting firm 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 document or project off your hands and drive it to 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-in the gaps in your team. irwin and associates has years of experience in the medical device industry. select the services tab to learn more about our proficiencies and 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!