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Technical Expertise for Compliant Ultrasound Repairs

As medical device repair companies navigate new compliance guidance, the need for specialized technical expertise has never been clearer. The FDA’s Final Guidance on medical device repairs mandates that hospital suppliers and third-party servicers restore devices to original equipment manufacturer (OEM) specifications during servicing. For remanufacturing, the FDA requires a 510(k) clearance submission. Validating compliance in either scenario demands rigorous quantitative testing to ensure repaired devices function according to OEM specifications or receive FDA approval. Given the complexity of medical devices, this validation process requires deep technical knowledge, which can be challenging to find for some devices. Fortunately, finding the right expertise for ultrasound devices isn’t a problem for companies that partner with Acertara.

Achieving and validating FDA compliance

The FDA provides detailed guidance on testing and maintaining medical devices to ensure they meet strict safety and efficacy requirements. This is especially important for ultrasound devices, where the distinction between routine servicing and remanufacturing must be clearly defined due to its regulatory implications. Misclassifying these activities can lead to noncompliance, resulting in potential legal issues, costly recalls, market bans, and — above all — avoidable risks to patients.

Moving forward, medical devices must undergo thorough performance verification to confirm they operate safely and effectively across various conditions. Each component should be meticulously tested to meet OEM or FDA performance metrics. Accurate documentation of these processes is also needed to demonstrate compliance and support ongoing quality assurance efforts, making regulatory reviews smoother and ensuring long-term device reliability.

Challenges in ultrasound device testing

Ultrasound technology is both sophisticated and sensitive, making its testing particularly challenging. Minor variations in performance can significantly impact diagnostic accuracy and patient safety, which is why evidence-based quality assurance is imperative. Key factors contributing to these challenges include:

• Piezoelectric elements: The core of ultrasound technology, these elements must be precisely calibrated to produce accurate acoustic outputs. Any variation can lead to substantial differences in image quality.
• Electronic circuitry: Ensuring the seamless operation of the device, this circuitry requires thorough testing to prevent malfunctions that could disrupt clinical workflows and cause harm to patients and providers.
• Performance consistency: Devices must perform reliably under diverse clinical scenarios, requiring advanced testing methodologies to identify potential issues before they affect patient care.
• Fault detection and analysis: Identifying and rectifying faults at a granular level is critical for maintaining device reliability. Sophisticated diagnostic tools are essential for pinpointing issues and implementing corrective actions.

The complexity of ultrasound devices necessitates technical expertise capable of addressing these challenges head-on and ensuring compliance.

Acertara’s unmatched technical expertise

• Our experience: The team at Acertara comprises seasoned ultrasound experts who have spent decades developing, commercializing, and refining ultrasound systems. This depth of experience allows us to navigate complex technical challenges and provide industry-leading solutions.

• Our certifications and accreditations: Acertara operates an ISO/IEC 17025:2017 accredited acoustic measurement laboratory and an ISO 13485:2016 certified probe repair facility. These certifications are highly regarded in the medical device industry, reflecting the team’s commitment to maintaining the highest standards of quality and technical competence.
• Our innovation: Acertara’s team has always been at the forefront of innovation in ultrasound technology, having been involved in the development of over 20 technologically intensive ultrasound systems. We’ve also coauthored more than 40 U.S. patents related to ultrasound device engineering.
• Our industry leadership: Key members of the Acertara team hold significant positions in industry organizations, such as the NEMA/MITA Ultrasound Section. Our involvement in these bodies is a testament to our expertise and influence on industry standards and practices.
• Our solutions: Our state-of-the-art testing facilities — equipped with advanced tools like the ATLAS Ultrasound Probe Tester and AmpSafe Leakage Current Test Unit — deliver precise and comprehensive evaluations. These technologies enable Acertara’s experts to conduct thorough testing, ensuring that each device adheres to regulatory requirements and aggressive standards for patient safety.

FDA 510(k) submission assistance

Acertara has been directly involved in the successful filing of more than 3000 FDA 510(k) submissions for ultrasound systems and related devices. Our comprehensive understanding of regulatory requirements ensures ultrasound technology meets stringent safety and performance standards. We provide expert guidance and technology for preparing 510(k) submissions, ensuring compliance with FDA requirements and facilitating faster market clearance.

Partner with experts at Acertara

Technical expertise is essential for compliance and safety. Acertara exemplifies this commitment through its advanced facilities, skilled team, and dedication to excellence in testing. By prioritizing precision and compliance, Acertara ensures that healthcare providers have access to safe, reliable ultrasound devices. Ultimately, this improves patient care and outcomes. As the industry continues to evolve, the role of technical expertise in achieving compliance will remain critical, guiding the way toward enhanced healthcare solutions.