Welcome to MyRAQA

MyRAQA is a full-service IVD Regulatory consulting firm.  Founded in 1998 as a solo practice, MyRAQA has grown to include leading experts in RA, QA, Design Control, Process Development, Systems Integration and Project Administration.

MyRAQA serves a wide range of clients, including established players up & comers and even stealth startups. MyRAQA has worked on a full range of IVD applications in the US and EU, including PMAs, pre-IDEs, IDEs, 501(k)s, de novo 510(k)s, and EU technical files.

But MyRAQA is more than just a collection of expertise.  We're a team that's dedicated to helping our clients succeed.

Our guiding principle here at MyRAQA is short and sweet:

Do Good Work

More specifically, our motto means:

• We do work that is socially good
  We believe that medical products and services will enhance human life when they pass scientific and regulatory muster.  We believe that we can and should contribute to general human welfare in how we choose to do our work
  
  
• We do work that is of high quality
  Because our work is important, it is worth doing as well as possible.  We provide expertise that is informed, well-reasoned, and tailored to meet specific client needs.  We provide services that are of exceptionally good value
  
  
• We actually do the work
  MyRAQA is not in the business of dispensing empty advice.  We have expertise because we seek to be involved in the difficult work.

We're excited about being involved in the ever-changing IVD industry.  Please take a look around to get a sense of who we are and what we're about.  We look forward to hearing about what you're working on and how we can help bring it to its full potential.