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...
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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...
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)...
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...
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...
Why the FDA’s Final Guidance on Remanufacturing Is a Boon for Patient Safety
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....
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...
Providing Safer Medtech Solutions with Portable Ultrasounds & Reduced Ionizing Radiation
If the digital age has taught us anything, it’s that information is valuable — and powerful. This has always been a fundamental truth in the world of healthcare. Today, we’re seeing a marriage of...
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...
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...
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...
The Future of Point-of-Care and Ultrasound Diagnostics
Ultrasound technology — a longtime staple in medical imaging — is now emerging as a pivotal tool in the evolution of point-of-care diagnostics. This leap forward is marked by accessible...