1. Home
  2. Uncategorized

Uncategorized

Medical Worker Touch Plus Icon For Health Care

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 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

September 10, 2024 Uncategorized
Modern Ultrasound Machine Scanner

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 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

September 5, 2024 Uncategorized
quantitative ultrasound testing

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 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

July 29, 2024 Uncategorized
Concept Of Medicine And Pharmacy Standards Compliance

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 Uncategorized
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 Uncategorized
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 Uncategorized
Doctor,Writing,Marker,A,Fda,Abbreviation,On,Virtual,Touch,Screen.

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 Uncategorized

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 Uncategorized
News Categories
Recent Posts
Predictions for 2025 January 3, 2025
Chad Steffl Employee Spotlight: Chad January 3, 2025