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Quantitative Testing for Ultrasound Devices

The FDA’s Final Guidance on medical device remanufacturing has underscored the critical need for quantitative testing. This type of testing is essential to ensuring compliance with their Guidance because it verifies that devices meet stringent safety and performance standards. Achieving accurate and reliable quantitative testing isn’t feasible without the right combination of advanced technology and specialized subject-matter expertise. For healthcare organizations (HCOs) committed to compliance, partnering with a medical device repair expert with cutting-edge tools and a knowledgeable team is more important than ever.

Technology for quantitative ultrasound testing

Quantitative testing relies on advanced technology to provide the precise data essential for compliance with the FDA’s Final Guidance. Acertara’s ultrasound performance-testing equipment exemplifies this:

ATLAS Ultrasound Probe Tester

The ATLAS system includes a transmit pulser, receiver, impedance measurement module, and other advanced components that ensure precise measurements. These features allow for rapid validation, reducing downtime and ensuring medical devices are quickly and accurately assessed for compliance. For instance, the system’s ability to measure complex impedance and perform pulse/echo measurements provides comprehensive data essential for maintaining device performance standards. The three-axis positioning system and the ability to conduct complex impedance measurements are crucial for maintaining the integrity of sophisticated ultrasound functions.

AmpSafe

Acertara’s AmpSafe device enhances safety compliance by providing advanced diagnostic capabilities for electrical leakage. This device ensures various makes and models of diagnostic ultrasound transducers meet safety standards for patients and providers alike. AmpSafe can also conduct continuous measurement in meter mode and its cloud-based operation for instant reports.

Quantitative testing for medical device compliance

Quantitative testing is a critical process for ensuring the safety and efficacy of medical devices. This type of testing involves precise, objective measurements of a device’s functionality. It generates reproducible data to demonstrate device performance and compliance with regulatory guidance.

By ensuring devices meet OEM specifications, quantitative testing plays a vital role in protecting patient safety. This type of testing helps prevent device malfunctions that could lead to inaccurate diagnoses or ineffective treatments. It is also essential for avoiding unintentional remanufacturing, which can lead to regulatory noncompliance and potential risks to patient safety.

Ultrasound engineering and repair

Acertara’s extensive expertise in ultrasound system design, measurement, and regulatory compliance enriches the accuracy and reliability of our testing services.

Our engineers are extensively trained in the latest consensus standards and practices, staying up to date with current regulatory guidance and advancements in ultrasound technology. Our team’s expertise allows us to handle complex and high-frequency probes, such as the Philips X5-1c and X8-2t.

Our team’s deep knowledge of ultrasound technology and regulatory guidance positions us as a leader in the field, capable of providing the highest-quality testing and repair services. Our success in supporting filings of nearly 3000 510(k) submissions is a testament to our intensive competencies in regulatory frameworks.

Benefits of partnering with Acertara

Acertara’s ISO/IEC 17025:201-accredited laboratory ensures all testing meets the FDA recognized consensus standards.

• Precision and reliability: Our state-of-the-art equipment and experienced team deliver precision and reliability for all ultrasound probe repairs. This ensures devices are not only compliant but also effective and safe for patient use.
• Comprehensive documentation: Our services include cloud-based documentation, providing clients with detailed reports and real-time updates on the status of their devices. This transparency enables informed decision-making about device maintenance and repair.
• Cost-effective solutions: By identifying and addressing potential issues early through quantitative testing, Acertara helps clients minimize repairs, extend device lifecycles, reduce downtime, and mitigate costly fines associated with noncompliance.
• Compliance with FDA Final Guidance: Acertara’s expertise and advanced technology ensure all testing and repair processes comply with the FDA’s Final Guidance on remanufacturing and ultrasound servicing. This allows our partners to avoid potential regulatory penalties while simultaneously improving patient care.

Choose Acertara for reliable, safe ultrasound repair services

Advanced technology and specialized expertise are paramount in achieving accurate, reliable quantitative testing results — which is now a cornerstone of compliance with the FDA’s Final Guidance on device remanufacturing. At Acertara, these requirements aren’t new to us; in fact, they’ve been part of our commitment to quality and patient safety for decades. For hospitals, OEMs, and third-party suppliers equally dedicated to ultrasound device safety, back your repairs and servicing with objective data through quantitative testing. Find the technology, expert partners, and ISO17025:2017 accredited acoustic laboratory you need at Acertara.