Providing expert consultants to help medical device companies

succeed at all stages of the product life-cycle.


Irwin & Associates provides medical device consulting services to help companies at all different phases of short and long- term projects.  We match companies with consultants who are experts in the industry and are ready to deliver technical support, innovative solutions, and attention to detail to help your company move forward.  


Irwin Consultants have helped many companies succeed on numerous projects and it is always satisfying to see hard work result in gratifying results.  Our clients are important to us and we very much appreciate their kind words.  We are currently working with many of the top Bay Area Medical Device Companies and would love to add your company to the list. 


We provide full-cycle Medical Device Documentation, Quality Systems, Design Control, Regulatory Support, Quality and Manufacturing expertise, Validation / Verifications, Product Transfers, Sterilization / Microbiology, Technical Writing, and Project Management.  We are ready to jump in and start helping you succeed.