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Expert Medical Device Consultants

Irwin & Associates, Inc.

SERVICES

  • Regulatory pathway and submissions

  • QMS creation / implementation 
  • Internal audits / Supplier audits
  • Technical Writing
  • Quality Engineering
  • Project Management
  • Risk Management / Design Control
  • SaMD

CLIENTS

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 others throughout the US and Europe.  We would love to add you to the list.

YOUR SUCCESS

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.

OUR  EXPERTISE

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Seeing  Success

When you are successful, we are successful. We are prepared to hit the ground running to make quick progress by providing top-notch, experienced Medical Device Professionals. We are able to make a difference by using engineering expertise along with thorough knowledge of regulations to fill in the gaps.   

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How to get started

  • Contact us to discuss your project needs

  • ​Receive resumes of qualified consultant

  • Discuss total project cost or hourly rate

  • Complete contract
  • Kick off project support
Clients

CLIENTS

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TESTIMONIALS

"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." ​​

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Head of Quality, Verily

Grace Li

Contact
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