Custom regulatory consulting services for in vitro diagnostic and medical device companies. TAGA Consulting specializes in early strategic planning that unites Regulatory, Clinical, Quality, and Commercial concerns, and helps clients achieve success by: developing effective regulatory roadmaps and clarifying requirements; designing clinical studies that meet expectations for clinical evidence and design validation; formulating comprehensive analytical study plans; creating, reviewing, evaluating, and editing regulatory submissions to ensure a cohesive narrative and on-point messaging.

• Directed Regulatory, Clinical, and Assay Development activities that achieved Health Canada authorization of RALI-Dx IL-6 Severity Triage Test for COVID-19 assessment.• Led cross-functional audit team through ISO 13485 / MDSAP extension audit with no non-conformances.• Oversaw Quality Management System (QMS) process improvement projects for complaint handling, non-conformances, and corrective and preventive action (CAPA) to integrate risk management and ensure compliance with ISO 14971, ISO 13485, 21 CFR 820, and SOR 98-282. • Developed regulatory strategy for novel, multiplexed IVD test for cytokines in lungs undergoing ex-vivo perfusion prior to transplantation.

• Key Clinical Affairs contributor to US Department of Defense proposal to develop a novel, point of care IVD product for traumatic brain injury (TBI) on the i-STAT System. Abbott was awarded the $35 million contract.• Developed a phased approach to the TBI pre-market regulatory submissions and clinical studies, reducing the time to market for the first TBI product by 2 years. Achieved plan buy-in from US FDA and US DoD.

• Primary author of 510(k) for hematocrit test (K163342), Special 510(k) for potassium test, and technical file for CE Marking of new i-STAT Alinity IVD test system (13 tests).• Negotiated regulatory strategy via Q-submissions and in-person meetings with FDA.

• Pioneered a new role within Abbott Point of Care, taking responsibility for clinical and regulatory strategy, cross-divisional execution of near-patient IVD clinical studies, and compliance with GCP and 21 CFR 812.

• Directed feasibility assessment for Thyroid Stimulating Hormone immunoassay: identified technical challenges, employed statistical techniques to drive to solutions, and demonstrated assay feasibility on time.

• Led execution of US Clinical Laboratory Improvement Amendments (CLIA) Waiver studies for brain natriuretic peptide (BNP) test and prothrombin time (PT) test. Authored regulatory submissions.

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