Joshua Yao

Provide strategic regulatory counsel to domestic and international medical device companies (startups to multinational corporations) across the full product lifecycle, from pre-market approval strategy and submissions to post-market compliance and enforcement. • Advise clients on optimizing regulatory pathways for novel and complex medical technologies, often overcoming prior FDA challenges to secure market authorization. • Develop and execute pre-market strategies, preparing and filing comprehensive FDA submissions including PMAs, IDEs, De Novo Requests, 510(k)s, 513(g)s, and Pre-Submissions. • Leverage technical expertise in clinical study design, hazard/risk management (FMEAs), electrical safety/EMC (IEC 60601), software/cybersecurity (IEC 62304), and biocompatibility/TRA (ISO 10993/18562) to support successful FDA submissions. • Design and implement robust post-market surveillance programs and Quality Management Systems (QMS compliant with FDA QSR & ISO 13485), including SOP development and company training. • Strategize and manage responses to FDA 483 inspection observations, Warning Letters, and enforcement actions, advising on CAPA implementation and recall systems. • Counsel clients on advertising and promotional materials to ensure consistency with FDA clearances/approvals and mitigate regulatory risks.

• Lead Regulatory Reviewer: Managed the scientific and regulatory review of pre-market submissions (510(k), PMA, IDE, HDE, Breakthrough Designation, Pre-Submissions) for complex respiratory and anesthesia devices. • Investigator & Compliance SME: As an accredited ORA Investigator, conducted on-site facility investigations of major device manufacturers, providing technical expertise on FDA 483s, QMS, CAPAs, and recall strategies. • Cross-Functional Leadership: Pioneered critical cross-center review teams (CDER, OSEL, ORA, Chief Counsel) to address urgent industry safety signals, particularly in the ventilator space. • COVID-19 EUA Lead: Served as Technical SME during the COVID-19 pandemic, reviewing 50+ Emergency Use Authorization (EUA) submissions for ventilators and standardizing novel inter-center regulatory processes. • International Standards Expert: Acted as FDA's technical SME and point-of-contact for international standards committees, including ISO 80601-2-74 and AAMI Working Groups (Respiratory Gas, Anesthesia Equipment, Lung Ventilators).

• Invented in-vitro micro pulmonary models for quantification of ventilation-induced mechanical lung cell damage using fluorescent assays and microimaging. • Developed electric cell-substrate impedance-based analysis of cell wound repair during pulsatile flow in biomimetic airways. • Publication: "Electric Cell-Substrate Impedance Sensing (ECIS) as a Platform for Evaluating Barrier-Function Susceptibility and Damage from Pulmonary Atelectrauma", Biosensors, EISSN 2079-6374

• Assessed, extricated, treated, and transported patients via Louisiana Region 1 BLS ambulance protocols. • Oversaw regional protocol compliance, technical training, continuing quality improvement, and inter-agency relations for a 68-member BLS Agency. Collaborated with executive leadership in municipal- and state-level law enforcement and fire departments for implementation of Agency-wide growth and integration.