Jo-Ann Gonzales, RAC

Manager

Jo-Ann has over 12 years of regulatory experience, 10 of which have been specifically with IVDs. She comes to Myraqa having served in regulatory for four years at Novartis and six at BD.

Jo-Ann has developed global regulatory strategies, authored 510(k)s, participated in FDA meetings and created technical files for instruments, software and reagents. She has also reviewed product labeling, participated in FDA meetings and has supported product development in reviewing design control and manufacturing documents.

Jo-Ann earned a BS in Environmental Science from San Jose State University and has been Regulatory Affairs Certified since 1998.

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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)
Design Control
In Vitro Diagnostic (IVD)
Labeling