Jo-Ann Gonzales, RAC

Associate Director

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

BNP tests Reducing the time to treatment for patients with heart failure
HPV Tests Helping to allay women's fears about a life-threatening disease
Molecular Diagnostics for Influenza Making point-of-care diagnosis possible
Rapid Influenza Detection Tests Helping doctors decide who needs antivirals, and who needs chicken soup

Glossary Terms

510(k)
Design Control
In Vitro Diagnostic (IVD)
Labeling