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Expert Medical Device Consultants providing support throughout 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. 


It's always nice to be recognized for hard work and hard-earned goals.  We are proud of our team and the fantastic reputation that we have maintained.  Our clients see the difference in the service we provide and the wealth of knowledge and expertise that we can bring to each project.



Seeing  Success

When you are successful, we are successful. We are prepared to hit the ground running on your project by providing top-notch, experienced Medical Device Professionals. We are able to quickly learn about your project needs and make a difference by using engineering expertise along with thorough knowledge of regulations and expert writing ability to fill in the gaps.   

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Irwin Consultants have expertise in the following areas: 

  • Quality Engineering

  • Quality Systems

  • Manufacturing Engineering

  • Project Management

  • Sterilization/Biocompatibility

  • Verification/Validation

  • Process Development

  • Technical Writing

  • Design Control

  • R&D

  • Regulatory Strategy

  • Internal Auditing


We have expertise as individual contributors and Project Managers throughout the Medical Device life-cycle.


Some of our most recent projects include:

  • Design Control Project Management

  • Creating Quality Management Systems

  • Specification Documents and  Requirement Tracing

  • Quality Engineering Support for Improved Device

  • Verification / Validation of New Equipment

  • Process Development and Parameter Establishment

  • Regulatory Strategy and Submissions

  • R&D Project Management

  • Technical Writing for Complex Systems

  • Biocompatibility Projects





"I have had numerous engagements with Irwin & Associates over the last few years related to quality, manufacturing, and regulatory. All their consultants have been consummate professionals that have immediately brought in valuable expertise. Barbara is an absolute pleasure to work with and I highly recommend Irwin to anyone in the medical device industry."

Head of Quality, Verily

Grace Li