Shaily Shah

I have around 10 years of combined experience in Regulatory & Quality in Medical Device industry. I have 510(k) clearances published in FDA database on my name in gynecology, urology etc device categories . I hold Masters in Regulatory Affairs and an undergraduate degree in Pharmacy. I have worked with various types of medical devices i.e AI/ML SaMD, traditional and combination products. My experience include AI/ML SaMD regulatory strategy, authoring 510(k)/ De Novo submission, Q-submissions, responding to AINN deficiencies, SIR meetings, remediation of quality system, FDA inspection readiness & implementation of QMS compliant with 21 cfr 820/ISO 13485/ ISO 9001.

I have worked with CEO/founder & C-suite executive levels helping them navigate the regulatory pathway to meet their time & investment expectations. I am passionate of bringing novel technologies to the market and seeing the impact on real patient-care.