Mya Thomae, RAC, CQA

Founder and CEO

Mya has almost 20 years of experience with regulatory and quality, much of it as a consultant.  Prior to becoming a consultant, Mya learned the ropes at Chiron and OraSure.

Mya has been involved in numerous successful applications before FDA for clients in the US, Canada and EU.  She worked with FDA to develop the special controls document and regulation for microarray devices and helped establish the precedent for parallel 510(k) submissions. Mya received a Commissioner's Special Citation at the 2009 FDA Honor Awards in recognition of her work to clear the ABI 7500 Fast Dx.

Mya founded Myraqa (formerly Mya Thomae Consulting) in 2002, building on several years as an independent contractor.

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Recent Blogs

Great New Companion Diagnostics E-Book Released Today A valuable resource in a hot, but under-informed segment of the market
Oragene Clearance Shows DNA Stabilization is Class II Clearance could have a significant impact on DTCG providers
My Screening Test for Screening Tests Offering up a rare bit of regulatory certainty
The Abolish OIVD Act of 2011 A torches-and-pitchforks approach to LDT regulations

Glossary Terms

510(k)
Quality