Welcome to Myraqa

Myraqa is the leading IVD and companion diagnostic consulting firm. Founded in 1998 as a solo practice, Myraqa has grown to include leading experts in Regulatory, Quality, Clinical, Biostatistics and Development. 

Myraqa serves a wide range of clients, including established diagnostic and therapeutic companies, up & comers and even stealth startups. We work strategically with our customers to smooth the path toward regulatory success. Myraqa has worked on a full range of applications in the US and EU, including PMAs, pre-submissions, IDEs, 510(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.

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Recent Blogs

A First Look at a New Review Paradigm Working the bugs out of new methods for identifying bugs
FDA Announces New EUO Label Draft guidance will lay out new path for devices
Is Apple's Rumored Healthbook a Medical Device? Looking to re-invent the old "Apple a day" saying
Risk-Based Quality Management of Clinical Trials US and EU take (somewhat) similar approaches

Glossary Terms

510(k)
In Vitro Diagnostic (IVD)
Investigational Device Exemption (IDE)
Premarket Approval Application (PMA)
Quality