Wanisha Siripakdi is the Clinical and Regulatory Specialist for PyrAmes, and brings to the company two years of clinical and regulatory experience in preparing submission documents for clinical release and 510(k), PMA, IDE, and Q.Submission documents to obtain regulatory clearances.
Prior to PyrAmes, Wanisha was the Clinical and Regulatory Specialist for Avantac Vascular Corporation, working on various Class II and Class III vascular devices, like embolization coils for the neuro space, peripheral atherectomy devices, and drug eluting stents for above and below the knee. Wanisha was responsible for strategic planning for Non-Clinical, Preclinical, and Clinical testing, including drafting and reviewing documents such as Preclinical and Clinical protocols, Clinical Risk Assessments, and Justifications, for First-in-Human, 510(k), PMA, IDE, and Q.Submission documents within the US and OUS.
Wanisha has a BS in Biomedical Engineering from San Jose State University.
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