“Software failures were identified as the root cause in 24% of all medical device recalls, including infusion pumps, imaging systems, patient monitors, and diagnostic devices”- U.S. Food and Drug Administration (FDA Medical Device Recall Report, 2023–2024).
By 2025–26, healthcare quality failures are increasingly driven by software-centric medical devices and digital systems, not just clinical processes. Alarmingly, more than 90% of Class I recalls (the most serious category, involving risk of death or serious injury) were linked to design and software validation issues, rather than hardware defects. These failures underscore a critical reality: when medical devices are not rigorously tested across real-world scenarios, quality gaps directly translate into patient harm.
The Hidden Cost of Poor Quality
The human cost of inadequate quality assurance is well documented. A comprehensive analysis from Johns Hopkins University estimates that medical errors cause approximately 250,000 deaths annually in the United States, ranking as a leading cause of death. On the economic side, the World Health Organization estimates that unsafe care costs global health systems approximately USD 1 trillion every year, driven by adverse events, unnecessary diagnostics, repeat procedures, prolonged hospital stays, and litigation. These are not abstract losses; they are direct consequences of weak quality controls across devices, data, and digital workflows.
As healthcare organizations scale AI-enabled diagnostics, connected medical devices, and data-driven clinical platforms, quality assurance has become the final and most critical safety gate before patient intervention. Modern QA programs now encompass device software validation, data accuracy checks, interoperability testing, and real-world performance monitoring, ensuring that systems behave safely under clinical pressure. By uniting clinicians, data specialists, system integrators, and quality engineers, QA bridges gaps between people, processes, and technology. It reduces recall risk, prevents diagnostic errors, improves patient outcomes, and curbs avoidable financial losses. Ultimately, quality assurance ensures the right decision, for the right treatment, at the right time, protecting lives while preserving trust, compliance, and cost efficiency.
What can Quality Assurance (QA) do in healthcare?
For a Quality Assurance program to efficiently address the complex mix of processes, technologies, and stakeholders in healthcare, it must encompass all aspects of Total Quality Management (TQM). QA in healthcare is not a one-time activity or a downstream checkpoint—it is a continuous discipline that ensures quality is embedded across systems, data, and workflows. When implemented holistically, QA enables healthcare organizations to consistently deliver safe, reliable, and high-quality outcomes while supporting growth, compliance, and innovation.
Big Data – Quality Measures
As healthcare organizations handle massive volumes of data generated every hour from electronic health records, laboratories, imaging systems, devices, and applications, data quality becomes foundational to patient care. Gartner states, “Reliable, trustworthy, and accessible data is crucial to any healthcare organization’s ongoing ability to successfully orchestrate and pay for care, conduct research and deliver value in the expanding healthcare ecosystem, tackle another COVID-like disruption, and extract value from AI investments.” In this context, a QA program governs how data is collected, processed, analyzed, and consumed. It ensures that analytical models, algorithms, and business intelligence systems produce accurate and meaningful insights, enabling clinicians to detect patterns, intervene early, and make informed, evidence-based decisions that directly impact patient outcomes.
Security
Healthcare environments rely on multiple software programs and platforms that continuously exchange sensitive patient data across internal systems and external networks. As data flows across hundreds of providers, partners, and third-party systems, security risks increase, especially when compliance maturity varies across the ecosystem. With stricter government regulations and rising expectations for data privacy and protection, healthcare organizations must maintain uncompromising security standards. A robust QA program validates that software applications and data flows are secure, end-to-end, ensuring adherence to regulatory protocols without disrupting clinical operations or care delivery.
Integration Testing
Healthcare applications rarely operate in isolation. Data is constantly extracted, updated, and shared across multiple applications, modules, and departments within the same organization, often extending to connected medical devices. Integration testing ensures that these interconnected systems function cohesively and reliably. Through rigorous validation of interfaces, dependencies, and data exchanges, QA ensures that healthcare applications and devices work together as intended, eliminating failures caused by broken integrations, inconsistent data handoffs, or misaligned workflows.
Functional Testing
For healthcare software products and integrated applications, functional maturity is critical to delivering accurate performance and dependable services. Consider a hospital application that allows patients to customize and access care reports such an application must function flawlessly and reflect the most current data at all times. Functional testing validates processes, workflows, and system behavior across real-world scenarios. Performance measures are continuously evaluated by assessing outputs, execution, and implementation against defined parameters to ensure results are accurate and clinically reliable. As a result, functional testing supports higher-quality outputs within shorter development cycles while enabling comprehensive, end-to-end testing coverage across diverse environments and use cases.
A comprehensive and scalable QA program is therefore essential for any healthcare organization seeking sustainable growth. Successful QA implementation begins with cultivating the right culture and mindset, one that prioritizes quality in every deliverable, across every system, and at every stage of the healthcare value chain.
Conclusion
With decades of experience in healthcare and life sciences, Coforge enables organizations to move beyond fragmented testing toward enterprise-grade quality engineering. Coforge supports hospitals, pharmaceutical companies, diagnostic labs, payers, TPAs, medical device manufacturers, healthcare ISVs, and research organizations with end-to-end advisory, transformation, automation, performance, functional, security testing services and a plethora of healthcare & life sciences Industry solutions.
By aligning quality with regulatory expectations, clinical safety, and digital innovation, Coforge helps healthcare organizations deliver reliable, secure, and scalable care experiences without compromising outcomes, compliance, or cost efficiency.
About Coforge
Coforge is a global digital services and solutions provider that enables its clients to transform at the intersection of domain expertise and emerging technologies, achieving real-world business impact. A focus on very select industries, a detailed understanding of the underlying processes within those industries, and partnerships with leading platforms provide us with a distinct perspective. Coforge leads with its product engineering approach, leveraging Cloud, Data, Integration, and Automation technologies to transform client businesses into intelligent, high-growth enterprises. Coforge’s proprietary platforms power critical business processes across its core verticals. The firm has a presence in 24 countries with 30 delivery centers across nine countries.