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FDA Guidance Calls for Quantitative Testing

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

July 26, 2024 Blog
A Partnership With Acertara Is Built on Safety and Compliance

A Partnership With Acertara Is Built on Safety and Compliance

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

July 11, 2024 Blog
What Hospitals Need To Know About FDA Guidance on Medical Device Repair

What Hospitals Need To Know About FDA Guidance on Medical Device Repair

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

July 9, 2024 Blog
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Acertara: Your Partners in Compliance With FDA Guidance

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

May 30, 2024 Blog

How Ultrasound Accessibility is Growing Through Cost Effective Diagnostics & Treatment

In a perfect vision of society, healthcare would be universally accessible, with timely and effective treatment available to all. Yet the reality is often marred by challenges such as geographic isolation, financial constraints, and a scarcity of resources, all of which hinder access for many communities. Amid these challenges, advancements in medical technology are emerging … Continue reading

April 19, 2024 Blog

Technical Expertise in Ultrasound Engineering Translates to Value-Based Care

Ultrasound is a tried-and-true technology, applicable across a spectrum of clinical applications. It’s becoming more critical with the shift toward value-based care (VBC). Today’s technology offers decisive point-of-care ultrasounds, delivery, and treatment monitoring as part of complex care plans. Yet, unlocking the full potential of ultrasound in VBC requires more than just a skilled hand … Continue reading

February 15, 2024 Blog

Value-Based Care and Ultrasound Diagnostics: A Win-Win for Patients

Healthcare is in a period of necessary evolution, with traditional fee-for-service models giving way to a focus on delivering value: providing improved outcomes at lower costs. This journey requires innovative tools, and one imaging technology stands out: ultrasound. Its accuracy, efficiency, accessibility across a myriad of clinical applications, and lower cost are proving remarkably suited … Continue reading

February 13, 2024 Blog

Point-of-Care Ultrasound: Regulatory and Ethical Considerations

Point-of-care ultrasound (PoCUS) has rapidly gained traction in healthcare for its capacity to prompt faster diagnosis and treatment decisions. Still, the integration of PoCUS into regular healthcare practices raises important regulatory and ethical considerations. What constitutes appropriate training and certification for administering PoCUS procedures? How will equipment be repaired, and to what quality standards should … Continue reading

February 10, 2024 Blog
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