Quality as a Product Metric: How QA Leadership Translates Standards Compliance (HIPAA/FDA) into Measurable Growth

Citation: Kovalov Illia, "Quality as a Product Metric: How QA Leadership Translates Standards Compliance (HIPAA/FDA) into Measurable Growth", Universal Library of Engineering Technology, Volume 02, Issue 03.

Copyright: This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

This article examines the role of Quality Assurance (QA) as a product function in multiplatform development, including medical software subject to HIPAA and FDA requirements. The goal is to demonstrate how QA approaches and metrics (defect leakage, stability, SLOs, regression speed) can be translated into manageable business outcomes: user retention, conversion growth, reduced support costs, and lower compliance risks. The methodology is based on an analytical review of risk-based testing practices, test strategy design, quality monitoring implementation, and the synthesis of case studies from large U.S. projects. The results are presented as a “Quality ? Trust ? Revenue” model, where quality is described as a system of decisions: risk prioritization, the test pyramid, observability, provable compliance, and continuous regression control. The practical value of the study lies in proposing a set of KPIs and management rituals for product teams that enable quality to scale without disproportionate cost growth.

Keywords: QA Leadership; Product Quality; HIPAA; FDA; Risk-Based Testing; Defect Leakage; Quality Metrics; Regression; Observability; SLO.

https://doi.org/10.70315/uloap.ulete.2025.0203020