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
Recent FDA guidance on remanufacturing medical devices has shed light on the crucial distinction between repair and remanufacturing activities. Ensuring proper maintenance and repair of reusable medical devices is essential for both patient safety and continued functionality throughout equipment lifespan. Navigating the new guidelines and complying with the testing requirements can be a challenge for … Continue reading
In medicine, ensuring the safety and efficacy of equipment is paramount. From complex surgical tools to diagnostic instruments, medical devices play a crucial role in patient care — and the U.S. Food and Drug Administration (FDA) is at the forefront of mandating requirements to govern them. Specifically, the FDA releases guidance that sets the tone … Continue reading
