Ultrasound probe repair services must evolve with the increasing complexity of new ultrasound systems, particularly in probes used for specialized clinical applications. A one-size-fits-all approach to performance testing has never been ideal, but with the FDA’s Final Guidance on remanufacturing and servicing for medical devices, it’s no longer an option. A repaired probe must not … Continue reading
The rise of handheld point-of-care ultrasound (POCUS) devices has introduced new possibilities in medical diagnostics. But with their widespread adoption comes an important and often overlooked question: How will quality assurance in ultrasound technology look for PoCUS devices? As handheld PoCUS devices become more prevalent, questions surrounding their clinical accuracy and the need for robust … Continue reading
The healthcare industry relies on accurate diagnostics, and ultrasound technology plays a pivotal role in delivering real-time imaging that aids in critical decision-making. As ultrasound systems continue to evolve, so does the importance of maintaining these devices to ensure consistent, high-quality results. When it comes to ultrasound probe repair, transparency and trust between healthcare providers … Continue reading
The evolution of commercially available ultrasound technology is not solely driven by scientific innovation; it is closely intertwined with regulatory oversight that ensures safety, efficacy, and compliance. Among the regulatory bodies involved, the U.S. Food and Drug Administration (FDA) is ever at the forefront. Their guidance impacts every facet of ultrasound device development — from … Continue reading
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 … Continue reading
Precision testing plays a crucial role in the medical device industry, ensuring compliance with regulatory requirements and enhancing patient safety and treatment outcomes. In the field of ultrasound technology, precision testing extends beyond basic functionality checks to include detailed evaluations of each component, particularly at the acoustic element level of a probe. This approach objectively … Continue reading
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 … Continue reading
The U.S. Food and Drug Administration (FDA) recently issued Final Guidance on the definition and determination of what constitutes “remanufacturing” for reusable medical devices. This update aims to ensure consistency and adherence to federal regulations by original equipment manufacturers (OEMs) and third-party suppliers, distinguishing remanufacturing from servicing. This distinction clearly outlines the regulatory guidance entities … Continue reading
The recent release of the FDA’s Final Guidance on remanufacturing of medical devices sent ripples through the healthcare industry. This is especially true for healthcare organizations (HCOs) heavily reliant on reusable medical devices. This new guidance aims to clarify the distinction between servicing and remanufacturing activities, both of which are crucial for ensuring patient safety … Continue reading
The FDA’s Final Guidance on repair versus remanufacturing of medical devices has important implications for hospital suppliers. It goes beyond simple terminology — new definitions and requirements have real impacts on patient safety and hospital liability. Misinformation can lead to reputational damage and even legal repercussions. Understanding the key differences between repair and remanufacturing — … Continue reading
