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2024’s Compliance Updates for Quality Assurance in Ultrasound

The year 2024 marked significant advancements in regulatory frameworks for medical devices, especially ultrasound systems. The updates are not just about adhering to new rules but are a reminder of the growing need for quality assurance in ultrasound to support patient safety, diagnostic precision, and compliance with FDA requirements.

These changes reflect broader trends in how healthcare organizations (HCOs), manufacturers, and service providers are held accountable for the devices they produce, repair, or maintain. Let’s recap 2024’s compliance updates, their implications for the ultrasound industry, and the growing need for quantitative testing and quality assurance in ultrasound.

1. Strengthened FDA guidelines for servicing vs. remanufacturing

In 2024, the FDA further clarified the distinction between servicing and remanufacturing medical devices. While previous guidance addressed this topic, the 2024 updates leave no room for ambiguity. Key changes include:

• Comprehensive repair testing: All servicing activities now require quantitative testing, including acoustic output measurements, electrical safety checks, and system performance assessments. Testing must validate that devices meet their original equipment manufacturer (OEM) specifications without unintentionally altering performance parameters.
• Component traceability: Service providers must maintain detailed documentation for every replaced or repaired component, ensuring traceability for audits and long-term compliance.
• Remanufacturing oversight: Any activity that alters a device’s safety, efficacy, or intended use is now clearly classified as remanufacturing. Such activities require a 510(k) submission to demonstrate compliance with FDA regulations.

These strengthened guidelines for quality assurance in ultrasound demand greater investment in advanced testing equipment and protocols. Service providers must embed testing into every repair or remanufacturing process.

2. Continuous compliance monitoring

One-time inspections and reactive compliance will not work in 2025. Regulatory bodies are emphasizing continuous compliance monitoring, pushing organizations to adopt proactive testing and to beware of fabricated test results. Continuous monitoring ensures compliance, and it improves device longevity and diagnostic reliability, reducing the risk of unexpected downtime or costly repairs.

Some modern ultrasound systems now include sensors capable of monitoring parameters like acoustic power, probe sensitivity, and harmonic generation in real time. These metrics allow HCOs to detect performance drift before it impacts patient care. And integrated software solutions can centralize performance data from multiple devices, enabling real-time monitoring and automated compliance reporting. Such platforms simplify audit readiness and ensure consistent quality assurance in ultrasound across facilities.

3. Quality assurance for AI-powered ultrasound

Artificial intelligence (AI) has unlocked profound potential for modern ultrasound technology. As AI-powered ultrasound platforms become more sophisticated, regulators have introduced new requirements to ensure devices are used responsibly and effectively.

• Algorithm validation: AI systems must undergo rigorous validation to demonstrate that their outputs are consistent, reliable, and unbiased. This includes testing for edge cases and ensuring data used for training reflects diverse patient populations.
• Periodic recalibration: AI-driven ultrasound systems must be recalibrated regularly to account for changes in clinical environments or patient demographics.
• Documentation and transparency: Manufacturers must provide detailed documentation outlining how AI algorithms make decisions, their limitations, and potential biases.

These requirements underscore the complexity of maintaining quality assurance in ultrasound as AI continues to evolve.

4. Updates to ISO standards and accreditations

The International Organization for Standardization (ISO)’s existing standards for medical devices have expanded in scope. To align with standards for ISO/IEC 17025:2017 accreditation in 2025, testing laboratories must demonstrate greater traceability in their calibration methods, ensuring absolute reliability in performance testing.

And the International Electrotechnical Commission (IEC) introduced key updates to safety standards for ultrasound devices. Per IEC 60601-2-37 revisions, updated safety standards for ultrasound devices include stricter acoustic output thresholds to reduce risks to patients and operators during prolonged use.

Compliance with these updates is essential for maintaining international market access. These changes reinforce the importance of quality assurance in ultrasound to ensure safety and functionality.

Implications for stakeholders

• Manufacturers must integrate enhanced testing protocols during production and provide detailed documentation to meet updated ISO and FDA requirements.
• Healthcare providers need to collaborate with accredited service providers and invest in tools for continuous compliance monitoring.
• Third-party servicers must ensure every repair aligns with FDA and ISO regulations, leveraging quantitative testing and traceable documentation.

Prioritize quality assurance in ultrasound for 2025

The updates introduced in 2024 serve as a reminder that quality assurance in ultrasound is not just about meeting regulatory requirements — it’s about ensuring diagnostic integrity, patient safety, and operational excellence. Organizations that embrace these changes will be better positioned to navigate the future of ultrasound technology.