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...
Blog
Quality Assurance in Ultrasound: New PoCUS Technology — and New Questions
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...
Transparency and Trust in Ultrasound Probe Repair Services
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...
FDA Guidance Shapes the Future of Ultrasound and Medical Device Repair Companies
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...
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...
The Acertara Advantage: Precision Testing for Patient Safety
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...
Quantitative Testing for Ultrasound Devices
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...
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....